Trial Outcomes & Findings for A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies (NCT NCT02118337)

Last Updated: 2021-06-01

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Results posted on

2021-06-01

Participant Flow

The study is conducted in Australia, Canada, Europe and the USA.

Participant milestones

Participant milestones
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Overall Study STARTED	4	5	3	3	9	6	4	42	21
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	5	3	3	9	6	4	42	21

Reasons for withdrawal

Reasons for withdrawal
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Overall Study Other	1	0	0	0	2	3	1	28	15
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	1	0
Overall Study Withdrawal by Subject	1	3	2	1	2	2	1	4	2
Overall Study Death	2	2	1	2	5	1	2	9	4

Baseline Characteristics

A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=4 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg n=42 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg n=21 Participants Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Total n=97 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 12.6 • n=5 Participants	67.4 years STANDARD_DEVIATION 8.4 • n=7 Participants	52.3 years STANDARD_DEVIATION 17.9 • n=5 Participants	62.3 years STANDARD_DEVIATION 11.6 • n=4 Participants	62.1 years STANDARD_DEVIATION 11.0 • n=21 Participants	69.5 years STANDARD_DEVIATION 9.9 • n=8 Participants	64.8 years STANDARD_DEVIATION 14.2 • n=8 Participants	61.0 years STANDARD_DEVIATION 9.8 • n=24 Participants	59.1 years STANDARD_DEVIATION 10.5 • n=42 Participants	61.5 years STANDARD_DEVIATION 10.6 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	9 Participants n=24 Participants	6 Participants n=42 Participants	29 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	33 Participants n=24 Participants	15 Participants n=42 Participants	68 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	40 Participants n=24 Participants	20 Participants n=42 Participants	89 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	34 Participants n=24 Participants	16 Participants n=42 Participants	80 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	7 Participants n=24 Participants	2 Participants n=42 Participants	10 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase Any TEAE	4 Participants	5 Participants	3 Participants	3 Participants	9 Participants	6 Participants	—	—	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase Any TESAE	1 Participants	1 Participants	1 Participants	2 Participants	6 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-escalation phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters are defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Amylase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hyperuricaemia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hypoalbuminaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hypokalaemia	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hypomagnesaemia	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hyponatraemia	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hyperkalaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hypermagnesaemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Lipase increased	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hypercalcaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Hyperglycaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase proteinuria	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Anaemia	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Iron deficiency anaemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Leukocytosis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Lymphopenia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Activated partial thromboplastin time prolonged	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Blood fibrinogen decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase International normalized ratio	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Lymphocyte count decreased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Prothrombin time prolonged	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase White blood cell count decreased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Alanine aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Blood alkaline phosphatase increased	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Blood creatinine increased	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Blood phosphorus decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Blood urea increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase Gamma glutamyltransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-escalation phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Sinus tachycardia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Atrial fibrillation	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Palpitations	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Tachycardia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Pyrexia	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Weight decreased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase Hypertension	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase Tachycardia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase Palpitations	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase Atrial fibrillation	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase Sinus tachycardia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase Pericardial effusion	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The ORR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase	0 Percentage of participants Interval 0.0 to 60.2	16.7 Percentage of participants Interval 7.0 to 31.4	23.8 Percentage of participants Interval 8.2 to 47.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase NE	0 Participants	1 Participants	2 Participants	—	—	—	—	—	—
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase CR	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase PR	0 Participants	5 Participants	5 Participants	—	—	—	—	—	—
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase SD	3 Participants	17 Participants	8 Participants	—	—	—	—	—	—
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase PD	1 Participants	17 Participants	6 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at \>= 8 weeks and \>=24 weeks are reported.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase DCR at >=24 weeks	50.0 Percentage of participants Interval 6.8 to 93.2	38.1 Percentage of participants Interval 23.6 to 54.4	38.1 Percentage of participants Interval 18.1 to 61.6	—	—	—	—	—	—
Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase DCR at >=8 weeks	75.0 Percentage of participants Interval 19.4 to 99.4	57.1 Percentage of participants Interval 41.0 to 72.3	61.9 Percentage of participants Interval 38.4 to 81.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=7 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase	—	1.8 Months Interval 1.7 to 9.1	1.8 Months Interval 1.6 to 7.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=7 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase	—	NA Months Interval 12.9 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 4.4 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase	5.5 Months Interval 2.2 to 7.4	3.6 Months Interval 2.0 to 5.5	3.6 Months Interval 1.9 to 13.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Overall Survival in Dose-expansion Phase	19.9 Months Interval 7.0 to 19.9	NA Months Median and lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 12.0 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The BOR includes CR, PR, SD, PD, and NE per Modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase PD	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants	1 Participants	—	—	—
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase CR	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase PR	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants	4 Participants	—	—	—
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase SD	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	—	—	—
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase NE	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The ORR is defined as best overall response of confirmed CR or confirmed PR based on modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase	50.0 Percentage of participants Interval 6.8 to 93.2	0 Percentage of participants Interval 0.0 to 52.2	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8	44.4 Percentage of participants Interval 13.7 to 78.8	66.7 Percentage of participants Interval 22.3 to 95.7	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at \>= 8 weeks and \>=24 weeks are reported.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase DCR at >= 8 weeks	75.0 Percentage of participants Interval 19.4 to 99.4	20.0 Percentage of participants Interval 0.5 to 71.6	33.3 Percentage of participants Interval 0.8 to 90.6	33.3 Percentage of participants Interval 0.8 to 90.6	66.7 Percentage of participants Interval 29.9 to 92.5	83.3 Percentage of participants Interval 35.9 to 99.6	—	—	—
DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase DCR at >= 24 weeks	50.0 Percentage of participants Interval 6.8 to 93.2	0 Percentage of participants Interval 0.0 to 52.2	33.3 Percentage of participants Interval 0.8 to 90.6	0 Percentage of participants Interval 0.0 to 70.8	44.4 Percentage of participants Interval 13.7 to 78.8	83.3 Percentage of participants Interval 35.9 to 99.6	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=2 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=1 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase	2.6 Months Interval 1.6 to 3.5	—	3.4 Months Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	3.5 Months Interval 1.6 to 3.5	3.2 Months Interval 1.7 to 10.8	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: AAs-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The DoR was analyzed for those participants who achieved OR.

The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=2 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=1 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase	16.8 Months Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	NA Months Median and lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	7.4 Months Interval 5.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 5.6 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase	20.2 Months Interval 1.6 to 20.2	1.7 Months Interval 1.6 to 3.5	1.6 Months Interval 1.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	1.8 Months Interval 1.5 to 3.4	7.0 Months Interval 1.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	23.4 Months Interval 1.8 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
OS in Dose-escalation Phase	16.3 Months Interval 3.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 4.2 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	14.7 Months Lower and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	7.9 Months Interval 1.5 to 7.9	12.8 Months Interval 3.1 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 29.6 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—

SECONDARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With TEAEs and TESAEs in Dose-expansion Phase Any TEAE	4 Participants	42 Participants	20 Participants	—	—	—	—	—	—
Number of Participants With TEAEs and TESAEs in Dose-expansion Phase Any TESAE	3 Participants	22 Participants	13 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-expansion phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood glucose increased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Anaemia	1 Participants	6 Participants	5 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Amylase decreased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood creatine increased	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Neutropenia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood iron decreased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Lymphocyte count decreased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Neutrophil count decreased	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Platelet count decreased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Platelet count increased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Prothrombin time prolonged	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase White blood cell count increased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Alanine aminotransferase increased	1 Participants	1 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Amylase increased	1 Participants	3 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Aspartate aminotransferase increased	1 Participants	2 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood alkaline phosphatase increased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood bilirubin increased	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood creatine phosphokinase increased	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood creatinine increased	1 Participants	4 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood triglycerides increased	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase C-reactive protein increased	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Lipase increased	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Transaminases increased	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypercalcaemia	0 Participants	6 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hyperglycaemia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hyperkalaemia	0 Participants	2 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypertriglyceridaemia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypoalbuminaemia	0 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypocalcaemia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypoglycaemia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypokalaemia	0 Participants	5 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypomagnesaemia	0 Participants	4 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hyponatraemia	1 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Hypophosphataemia	0 Participants	1 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Urine abnormality	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood thyroid stimulating hormone increased	0 Participants	2 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase Blood urine present	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-expansion phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Atrial fibrillation	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Tachycardia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Pyrexia	2 Participants	9 Participants	2 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Weight decreased	0 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Weight increased	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Hypoxia	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Hypertension	1 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase Hypotension	1 Participants	2 Participants	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.

Number of participants in dose-expansion phase with abnormal ECG parameters reported as TEAEs are reported.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase Angina pectoris	1 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase Tachycardia	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase Atrial fibrillation	0 Participants	2 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase Cardiac failure congestive	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: The study did not meet its primary endpoint of demonstrating superior antitumor effect of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve participants with advanced or metastatic ccRCC as assessed by the investigator using RECIST v1.1. Therefore, the decision was made not to perform the BICR analysis for antitumor activity and hence data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant for dose-escalation phase and approximately 5 years 10 months for dose-expansion phase)

Population: Per the Statistical Analysis Plan, the data for percent change from baseline in target lesion was to be presented using Spider plot analysis. Hence, numeric data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1

Population: As-treated population included those participants who received MEDI0680 and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants who had quantifiable and calculable serum samples at the specified time points.

Serum concentration of MEDI0680 were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=4 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg n=40 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmin at Cycle1 Day1	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	—
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmax at Cycle1 Day1	4.330 μg/mL Geometric Coefficient of Variation 26.18	3.877 μg/mL Geometric Coefficient of Variation 54.68	16.36 μg/mL Geometric Coefficient of Variation 26.46	69.28 μg/mL Geometric Coefficient of Variation 24.76	272.4 μg/mL Geometric Coefficient of Variation 24.62	529.9 μg/mL Geometric Coefficient of Variation 29.84	668.8 μg/mL Geometric Coefficient of Variation 21.04	135.9 μg/mL Geometric Coefficient of Variation 4007	—
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmin at Cycle1 Day15	1.143 μg/mL Geometric Coefficient of Variation 22.70	0.9937 μg/mL Geometric Coefficient of Variation 35.93	4.428 μg/mL Geometric Coefficient of Variation 62.38	18.67 μg/mL Geometric Coefficient of Variation 12.88	46.87 μg/mL Geometric Coefficient of Variation 559.4	205.8 μg/mL Geometric Coefficient of Variation 24.56	—	—	—
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmax at Cycle1 Day15	5.420 μg/mL Geometric Coefficient of Variation 21.61	3.835 μg/mL Geometric Coefficient of Variation 25.30	20.52 μg/mL Geometric Coefficient of Variation 26.26	87.78 μg/mL Geometric Coefficient of Variation 20.69	348.1 μg/mL Geometric Coefficient of Variation 27.78	716.8 μg/mL Geometric Coefficient of Variation 26.72	—	—	—
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmin at Cycle2 Day1	1.645 μg/mL Geometric Coefficient of Variation 49.08	1.361 μg/mL Geometric Coefficient of Variation 38.07	7.879 μg/mL Geometric Coefficient of Variation 52.74	31.81 μg/mL Geometric Coefficient of Variation 4.480	155.7 μg/mL Geometric Coefficient of Variation 24.20	378.0 μg/mL Geometric Coefficient of Variation 17.95	308.6 μg/mL Geometric Coefficient of Variation 30.45	253.9 μg/mL Geometric Coefficient of Variation 52.11	—
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases Cmax at Cycle2 Day1	3.515 μg/mL Geometric Coefficient of Variation 145.9	3.688 μg/mL Geometric Coefficient of Variation 80.17	17.28 μg/mL Geometric Coefficient of Variation 56.32	92.07 μg/mL Geometric Coefficient of Variation 17.72	440.7 μg/mL Geometric Coefficient of Variation 28.18	860.8 μg/mL Geometric Coefficient of Variation 13.82	936.1 μg/mL Geometric Coefficient of Variation 24.91	586.6 μg/mL Geometric Coefficient of Variation 63.42	—

SECONDARY outcome

Timeframe: Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1

Population: As-treated population included those participants who received durvalumab and grouped according to actual treatment received. The "Number of participants Analyzed" denotes the number of participants who had quantifiable and calculable serum samples at the specified time points.

Serum concentration of durvalumab were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=41 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmin at Cycle1 Day1	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	NA μg/mL Geometric Coefficient of Variation NA The sample was not quantifiable; therefore, not calculable.	—	—
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmax at Cycle1 Day1	65.47 μg/mL Geometric Coefficient of Variation 10.02	216.1 μg/mL Geometric Coefficient of Variation 25.14	213.8 μg/mL Geometric Coefficient of Variation 9.943	188.0 μg/mL Geometric Coefficient of Variation 17.82	248.0 μg/mL Geometric Coefficient of Variation 27.20	253.9 μg/mL Geometric Coefficient of Variation 11.35	186.9 μg/mL Geometric Coefficient of Variation 33.42	—	—
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmin at Cycle1 Day15	19.62 μg/mL Geometric Coefficient of Variation 16.49	63.02 μg/mL Geometric Coefficient of Variation 7.836	49.04 μg/mL Geometric Coefficient of Variation 80.97	86.10 μg/mL Geometric Coefficient of Variation 69.76	79.59 μg/mL Geometric Coefficient of Variation 63.46	70.31 μg/mL Geometric Coefficient of Variation 22.00	—	—	—
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmax at Cycle1 Day15	95.14 μg/mL Geometric Coefficient of Variation 12.79	245.8 μg/mL Geometric Coefficient of Variation 13.45	241.1 μg/mL Geometric Coefficient of Variation 30.90	225.0 μg/mL Geometric Coefficient of Variation 9.213	292.7 μg/mL Geometric Coefficient of Variation 33.84	321.8 μg/mL Geometric Coefficient of Variation 23.05	—	—	—
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmin at Cycle2 Day1	23.83 μg/mL Geometric Coefficient of Variation 14.35	83.76 μg/mL Geometric Coefficient of Variation 34.29	89.20 μg/mL Geometric Coefficient of Variation 56.00	136.3 μg/mL Geometric Coefficient of Variation 45.72	124.8 μg/mL Geometric Coefficient of Variation 55.78	142.5 μg/mL Geometric Coefficient of Variation 50.52	78.41 μg/mL Geometric Coefficient of Variation 55.62	—	—
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases Cmax at Cycle2 Day1	84.43 μg/mL Geometric Coefficient of Variation 17.13	280.9 μg/mL Geometric Coefficient of Variation 12.48	297.5 μg/mL Geometric Coefficient of Variation 42.41	267.0 μg/mL Geometric Coefficient of Variation 25.97	370.9 μg/mL Geometric Coefficient of Variation 42.57	342.3 μg/mL Geometric Coefficient of Variation 18.08	258.1 μg/mL Geometric Coefficient of Variation 28.36	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)

Number of participants with positive ADAs to MEDI0680 are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>=2 post-baseline assessments (with \<16 weeks between first and last positive).

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=8 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=4 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg n=39 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases Persistent Positive	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases ADA positive post-baseline	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases Transient Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)

Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at \>=2 post-baseline assessments (with \<16 weeks between first and last positive).

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=8 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=39 Participants Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases ADA positive post-baseline	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases Persistent Positive	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	—
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases Transient Positive	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. Participants with PD-L1 positive (\> 1% tumor cell membrane or \> 1% immune cell staining) and PD-L1 negative (\<= 1% tumor cell membrane and \<= 1% immune cell staining) were evaluated for this outcome measure.

ORR for participants with PD-L1 status positive and negative are reported. The ORR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.

Outcome measures

Outcome measures
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=42 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=21 Participants Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase Participants with PD-L1 positive	0 Percentage of Participants Interval 0.0 to 97.5	40.0 Percentage of Participants Interval 5.3 to 85.3	37.5 Percentage of Participants Interval 8.5 to 75.5	—	—	—	—	—	—
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase Participants with PD-L1 negative	0 Percentage of Participants Interval 0.0 to 70.8	13.5 Percentage of Participants Interval 4.5 to 28.8	15.4 Percentage of Participants Interval 1.9 to 45.4	—	—	—	—	—	—

Adverse Events

MEDI0680 0.1 mg/kg + Durvalumab 3 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

MEDI0680 0.1 mg/kg + Durvalumab 10 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

MEDI0680 0.5 mg/kg + Durvalumab 10 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

MEDI0680 2.5 mg/kg + Durvalumab 10 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

MEDI0680 10 mg/kg + Durvalumab 10 mg

Serious events: 6 serious events

Other events: 9 other events

Deaths: 5 deaths

MEDI0680 20 mg/kg + Durvalumab 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

MEDI0680 20 mg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

MEDI0680 20 mg/kg + Durvalumab 750 mg

Serious events: 22 serious events

Other events: 41 other events

Deaths: 9 deaths

Nivolumab 240 mg

Serious events: 13 serious events

Other events: 20 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=4 participants at risk Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg n=42 participants at risk Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg n=21 participants at risk Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Infections and infestations Spinal cord infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Urinary tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Pericardial effusion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hyperthyroidism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hypothyroidism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Eye pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Colitis microscopic	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Haematemesis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Immune-mediated pancreatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Vomiting	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Chest pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Chills	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Fatigue	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Pyrexia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Cholecystitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Hepatocellular injury	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Cellulitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Device related infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Osteomyelitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Postoperative wound infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Alanine aminotransferase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Electrocardiogram qt prolonged	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Transaminases increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Failure to thrive	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Aphasia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Cerebrovascular accident	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Encephalitis autoimmune	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Headache	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Intracranial mass	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Seizure	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Mental status changes	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Hypotension	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Peripheral ischaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Other adverse events

Other adverse events
Measure	MEDI0680 0.1 mg/kg + Durvalumab 3 mg n=4 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg Q2W for up to 12 months.	MEDI0680 0.1 mg/kg + Durvalumab 10 mg n=5 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 0.5 mg/kg + Durvalumab 10 mg n=3 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 2.5 mg/kg + Durvalumab 10 mg n=3 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 10 mg/kg + Durvalumab 10 mg n=9 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg + Durvalumab 10 mg n=6 participants at risk Participants in dose-escalation phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.	MEDI0680 20 mg/kg n=4 participants at risk Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	MEDI0680 20 mg/kg + Durvalumab 750 mg n=42 participants at risk Participants in dose-expansion phase received IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.	Nivolumab 240 mg n=21 participants at risk Participants in dose-expansion phase received IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 3/9 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 10 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	23.8% 5/21 • Number of events 29 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Blood and lymphatic system disorders Leukocytosis	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Angina pectoris	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Cardiac failure congestive	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Palpitations	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Cardiac disorders Tachycardia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Ear and labyrinth disorders Ear discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Ear and labyrinth disorders Ear disorder	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Ear and labyrinth disorders Ear pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Ear and labyrinth disorders Tinnitus	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hyperthyroidism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Endocrine disorders Hypothyroidism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	40.0% 2/5 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Asthenopia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Conjunctival haemorrhage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Conjunctivitis allergic	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Diplopia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Dry eye	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Episcleritis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Eye irritation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Eye pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Eye pruritus	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Eyelid ptosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Keratitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Lacrimation increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Ocular hyperaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Periorbital swelling	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Photophobia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Vision blurred	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Eye disorders Visual impairment	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal mass	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Aphthous ulcer	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Ascites	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Colitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	40.0% 2/5 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	28.6% 12/42 • Number of events 16 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	28.6% 6/21 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	40.0% 2/5 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 3/9 • Number of events 12 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	83.3% 5/6 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	35.7% 15/42 • Number of events 23 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	42.9% 9/21 • Number of events 14 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Duodenitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Dysphagia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Epigastric discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Faeces soft	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Gingival bleeding	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Gingival pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Haemorrhoids	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Inguinal hernia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	66.7% 2/3 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	55.6% 5/9 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	75.0% 3/4 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	23.8% 10/42 • Number of events 13 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 7/21 • Number of events 8 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Odynophagia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Oral disorder	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Oral pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Gastrointestinal disorders Vomiting	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	26.2% 11/42 • Number of events 15 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	28.6% 6/21 • Number of events 8 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Asthenia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Axillary pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Catheter site pruritus	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Chest pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Chills	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Cyst	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Facial pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Fatigue	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	60.0% 3/5 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	100.0% 4/4 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	45.2% 19/42 • Number of events 25 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	28.6% 6/21 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Feeling hot	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Gait disturbance	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Inflammation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Influenza like illness	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Infusion site pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Malaise	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Mass	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Mucosal inflammation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Nodule	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Non-cardiac chest pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Oedema	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Oedema peripheral	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 3/9 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Pyrexia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	66.7% 2/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 3/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	50.0% 2/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 8/42 • Number of events 12 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Secretion discharge	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
General disorders Temperature intolerance	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Cholelithiasis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Hepatocellular injury	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Hepatotoxicity	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Hepatobiliary disorders Liver disorder	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Immune system disorders Allergy to arthropod sting	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Immune system disorders Contrast media reaction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Abscess	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Bronchiolitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Bronchitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Conjunctivitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Ear infection	50.0% 2/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Eye infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Gastrointestinal fungal infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Gingivitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Herpes zoster	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Hordeolum	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Influenza	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Kidney infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Lower respiratory tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Nasopharyngitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Oral candidiasis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Oral fungal infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Oral herpes	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Otitis media	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Pneumonia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Rash pustular	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Respiratory tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Rhinitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Sinusitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Tooth abscess	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Tooth infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	50.0% 3/6 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Urinary tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Viral infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Chemical burn of skin	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Post procedural oedema	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Rib fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Scratch	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Sunburn	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Injury, poisoning and procedural complications Wound	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Alanine aminotransferase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Amylase decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Amylase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 8 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 14 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood bilirubin increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood creatine increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood creatine phosphokinase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood creatinine increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood fibrinogen decreased	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood glucose increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood iron decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood phosphorus decreased	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood testosterone decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood thyroid stimulating hormone increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood triglycerides increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood urea increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Blood urine present	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations C-reactive protein increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Eastern cooperative oncology group performance status worsened	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Electrocardiogram qt prolonged	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Electrocardiogram t wave abnormal	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Gamma-glutamyltransferase increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations General physical condition abnormal	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Influenza b virus test positive	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations International normalised ratio increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Lipase increased	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 19 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 12 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Lymphocyte count decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Neutrophil count decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Platelet count decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Platelet count increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Procalcitonin increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Prothrombin time prolonged	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Serum ferritin decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Tri-iodothyronine free abnormal	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Weight decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations Weight increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations White blood cell count decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Investigations White blood cell count increased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Acidosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	66.7% 2/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Gout	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hyperuricaemia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 8 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	23.8% 10/42 • Number of events 18 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 7/21 • Number of events 12 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	40.0% 2/5 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	23.8% 10/42 • Number of events 11 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	25.0% 1/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Myalgia	50.0% 2/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Dizziness	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Dysgeusia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Facial paralysis	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Head discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Headache	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 6/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	23.8% 5/21 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Hyperaesthesia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Hyposmia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Lethargy	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Memory impairment	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Neuralgia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Neuropathy peripheral	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Paraesthesia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Sciatica	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Sensory disturbance	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Somnolence	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Nervous system disorders Tremor	50.0% 2/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Agitation	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Confusional state	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Delirium	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Depression	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Insomnia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Psychiatric disorders Mood altered	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Dysuria	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Micturition urgency	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Nocturia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Pollakiuria	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Proteinuria	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Renal tubular necrosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Urinary retention	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Urinary tract pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Renal and urinary disorders Urine abnormality	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Reproductive system and breast disorders Breast mass	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Reproductive system and breast disorders Galactorrhoea	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Reproductive system and breast disorders Pruritus genital	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	50.0% 3/6 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	21.4% 9/42 • Number of events 17 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	38.1% 8/21 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	22.2% 2/9 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 7/42 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	38.1% 8/21 • Number of events 10 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 7/42 • Number of events 8 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 4/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Sinus congestion	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Acne	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	9.5% 2/21 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Ecchymosis	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Erythema	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Macule	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	7.1% 3/42 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Papule	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	55.6% 5/9 • Number of events 10 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 7/42 • Number of events 10 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	14.3% 3/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash	50.0% 2/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	20.0% 1/5 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 1/3 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	44.4% 4/9 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	33.3% 2/6 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 7/42 • Number of events 9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	19.0% 4/21 • Number of events 5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Vitiligo	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Aortic aneurysm	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Aortic occlusion	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Deep vein thrombosis	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Embolism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/42 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Flushing	25.0% 1/4 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Hot flush	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Hypertension	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.1% 1/9 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	16.7% 1/6 • Number of events 3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	11.9% 5/42 • Number of events 7 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Hypotension	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	25.0% 1/4 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 2/42 • Number of events 2 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	4.8% 1/21 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Vascular disorders Vena cava embolism	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/5 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/3 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/9 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/6 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/4 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	2.4% 1/42 • Number of events 1 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)	0.00% 0/21 • Day 1 through 90 days post end of treatment (approximately 5 years 10 months)

Additional Information

Farzana Walcott

MedImmune, LLC

Phone: +1 301-398-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
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