Trial Outcomes & Findings for Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials (NCT NCT00828919)

Last Updated: 2024-12-03

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)

Results posted on

2024-12-03

Participant Flow

A total of 52 participants were enrolled in this study, out of which 49 were treated. Enrollment for this study was planned to be conducted into two groups: Axitinib monotherapy and Axitinib combination therapy. However, no participant enrolled in Axitinib combination therapy group.

Participants receiving axitinib in previous trials began this study with the last dose taken in the parent study. Participants continued to access axitinib on this study as long as there was documented stable disease, responding disease, or clinical benefit at the time of prior study closure.

Participant milestones

Participant milestones
Measure	Axitinib 2 mg Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.
Overall Study STARTED	7	9	20	2	11
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	7	9	20	2	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib 2 mg Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.
Overall Study Death	0	1	2	0	0
Overall Study Adverse Event	2	2	2	1	3
Overall Study Objective progression or relapse	4	4	11	0	5
Overall Study No longer willing to participate in study	0	0	2	0	0
Overall Study Insufficient Clinical Response	0	1	2	0	0
Overall Study Subject refused continued treatment for reason other than adverse event	0	0	0	0	3
Overall Study Other	1	0	1	1	0
Overall Study Lost to Follow-up	0	1	0	0	0

Baseline Characteristics

Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib 2 mg n=7 Participants Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg n=9 Participants Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg n=20 Participants Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg n=2 Participants Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other n=11 Participants Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.	Total n=49 Participants Total of all reporting groups
Age, Continuous	61.6 Years STANDARD_DEVIATION 14.7 • n=5 Participants	57.1 Years STANDARD_DEVIATION 11.3 • n=7 Participants	58.5 Years STANDARD_DEVIATION 4.2 • n=5 Participants	68.5 Years STANDARD_DEVIATION 3.5 • n=4 Participants	64.6 Years STANDARD_DEVIATION 8.6 • n=21 Participants	60.4 Years STANDARD_DEVIATION 9.0 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	14 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	35 Participants n=8 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
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants	32 Participants n=8 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)

Population: Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.

Outcome measures

Outcome measures
Measure	Overall n=49 Participants Participants received oral dose of Axitinib (any dose) alone twice daily as they were taking in the previous trial.	Axitinib 2 mg n=7 Participants Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg n=9 Participants Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg n=20 Participants Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg n=2 Participants Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other n=11 Participants Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs TEAEs	49 Participants	7 Participants	9 Participants	20 Participants	2 Participants	11 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs Serious TEAEs	21 Participants	4 Participants	8 Participants	5 Participants	0 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs Treatment Related TEAEs	47 Participants	7 Participants	9 Participants	18 Participants	2 Participants	11 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs Treatment Related Serious TEAEs	15 Participants	2 Participants	7 Participants	3 Participants	0 Participants	3 Participants

Adverse Events

Overall

Serious events: 21 serious events

Other events: 48 other events

Deaths: 5 deaths

Axitinib 2 mg

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

Axitinib 3 mg

Serious events: 8 serious events

Other events: 9 other events

Deaths: 1 deaths

Axitinib 5 mg

Serious events: 5 serious events

Other events: 19 other events

Deaths: 3 deaths

Axitinib 7 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Other

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall n=49 participants at risk Participants received oral dose of Axitinib (any dose) alone twice daily as they were taking in the previous trial.	Axitinib 2 mg n=7 participants at risk Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg n=9 participants at risk Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg n=20 participants at risk Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg n=2 participants at risk Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other n=11 participants at risk Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.
Blood and lymphatic system disorders Neutropenia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Acute coronary syndrome	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Acute myocardial infarction	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Arrhythmia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Cardio-respiratory arrest	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Intracardiac thrombus	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Myocardial infarction	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	55.6% 5/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Retinal vein occlusion	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Ascites	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Colitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Diarrhoea	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Enterocolitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gastric ulcer haemorrhage	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Nausea	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Vomiting	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Chest pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Disease progression	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Pyrexia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Hepatobiliary disorders Biliary obstruction	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Septic shock	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood creatinine increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Dehydration	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperkalaemia	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyponatraemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Aphasia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Dizziness	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Posterior reversible encephalopathy syndrome	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Transient global amnesia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Psychiatric disorders Confusional state	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Proteinuria	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Renal failure	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Surgical and medical procedures Cholecystectomy	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Hypotension	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.

Other adverse events

Other adverse events
Measure	Overall n=49 participants at risk Participants received oral dose of Axitinib (any dose) alone twice daily as they were taking in the previous trial.	Axitinib 2 mg n=7 participants at risk Participants received Axitinib 1 micrograms (mg) twice daily orally.	Axitinib 3 mg n=9 participants at risk Participants received Axitinib 1 mg twice daily.	Axitinib 5 mg n=20 participants at risk Participants received Axitinib 5 mg twice daily.	Axitinib 7 mg n=2 participants at risk Participants received Axitinib 5 mg plus Axitinib 1 mg twice daily.	Other n=11 participants at risk Participants who received Axitinib twice daily orally as dose other than 2 mg, 3 mg, 5 mg and 7 mg.
Blood and lymphatic system disorders Anaemia	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Blood and lymphatic system disorders Thrombocytopenia	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Endocrine disorders Hypothyroidism	32.7% 16/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	42.9% 3/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	44.4% 4/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	25.0% 5/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Abdominal pain	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Abdominal pain upper	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Constipation	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Diarrhoea	61.2% 30/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	42.9% 3/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 9/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 10/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 2/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	54.5% 6/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Dyspepsia	14.3% 7/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Nausea	22.4% 11/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 2/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Stomatitis	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Vomiting	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Asthenia	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Chest pain	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Chills	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Fatigue	42.9% 21/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	66.7% 6/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	30.0% 6/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 2/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	54.5% 6/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Influenza like illness	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Oedema	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Oedema peripheral	14.3% 7/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Pyrexia	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Nasopharyngitis	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Rhinitis	10.2% 5/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Sinusitis	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Tooth infection	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Upper respiratory tract infection	18.4% 9/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Urinary tract infection	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood cholesterol increased	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood creatinine increased	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Weight decreased	34.7% 17/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	55.6% 5/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	35.0% 7/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Decreased appetite	16.3% 8/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Dehydration	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperglycaemia	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperuricaemia	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Arthralgia	22.4% 11/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	42.9% 3/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	20.0% 4/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Back pain	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Myalgia	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Pain in extremity	18.4% 9/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Dizziness	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Headache	24.5% 12/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	20.0% 4/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Paraesthesia	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Taste disorder	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Psychiatric disorders Insomnia	10.2% 5/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	20.0% 4/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Dysuria	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Proteinuria	28.6% 14/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	71.4% 5/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	25.0% 5/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	27.3% 3/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Reproductive system and breast disorders Erectile dysfunction	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Cough	16.3% 8/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	20.0% 4/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Dysphonia	18.4% 9/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	15.0% 3/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 2/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	18.2% 2/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 3/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Alopecia	10.2% 5/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Dry skin	12.2% 6/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	28.6% 2/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	33.3% 3/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Hyperkeratosis	8.2% 4/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	38.8% 19/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	55.6% 5/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	35.0% 7/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	45.5% 5/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Rash	10.2% 5/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	22.2% 2/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Hypertension	57.1% 28/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	42.9% 3/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	77.8% 7/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	55.0% 11/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	100.0% 2/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	45.5% 5/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Blood and lymphatic system disorders Lymphopenia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Blood and lymphatic system disorders Polycythaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Angina pectoris	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Atrial fibrillation	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Bradycardia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Hypertensive heart disease	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Palpitations	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Cardiac disorders Sinus tachycardia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Ear and labyrinth disorders Ear pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Ear and labyrinth disorders Tinnitus	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Ear and labyrinth disorders Vertigo	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Endocrine disorders Thyroid disorder	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Endocrine disorders Thyroid mass	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Cataract	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Lacrimation increased	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Retinal vein occlusion	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Vision blurred	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Eye disorders Visual impairment	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Abdominal distension	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Angular cheilitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Colitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Dry mouth	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Duodenal ulcer	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Flatulence	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gastritis	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gastrointestinal motility disorder	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gastrointestinal tract irritation	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Gingival swelling	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Glossitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Glossodynia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Haematemesis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Melaena	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Oral pain	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Pancreatitis	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Periodontal disease	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Rectal haemorrhage	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Gastrointestinal disorders Tooth loss	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Chest discomfort	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Facial pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Hernia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Impaired healing	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Non-cardiac chest pain	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
General disorders Pain	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Hepatobiliary disorders Cholecystitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Hepatobiliary disorders Cholestasis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Hepatobiliary disorders Hepatic function abnormal	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Cystitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Erysipelas	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Folliculitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Gastroenteritis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Gastroenteritis viral	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Helicobacter infection	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Herpes zoster	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Influenza	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Liver abscess	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Otitis media	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Perichondritis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Pneumonia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Infections and infestations Tinea pedis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Injury, poisoning and procedural complications Arthropod bite	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Injury, poisoning and procedural complications Contusion	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Injury, poisoning and procedural complications Fall	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Injury, poisoning and procedural complications Sunburn	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Alanine aminotransferase increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Aspartate aminotransferase increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood creatine phosphokinase increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood magnesium decreased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood potassium decreased	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Blood triglycerides increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Carbon dioxide increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Chest X-ray abnormal	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Haematocrit increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Haemoglobin decreased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Heart rate increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations International normalised ratio increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Prostatic specific antigen increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Troponin increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations Urine protein/creatinine ratio increased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations White blood cell count	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Investigations White blood cell count decreased	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Diabetes mellitus	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Glucose tolerance impaired	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Gout	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperamylasaemia	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypercalcaemia	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypercholesterolaemia	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperkalaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperlipidaemia	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	10.0% 2/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyperphosphataemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypoalbuminaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypocalcaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypochloraemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypocholesterolaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hypokalaemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Hyponatraemia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Metabolism and nutrition disorders Polydipsia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Coccydynia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Gouty arthritis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Muscle spasms	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Osteoporosis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Aphasia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Carotid artery thrombosis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Dysgeusia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Hyperaesthesia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Memory impairment	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Nervous system disorders Radiculopathy	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Psychiatric disorders Confusional state	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Psychiatric disorders Depression	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Psychiatric disorders Mood altered	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Chromaturia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Chronic kidney disease	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Haematuria	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Renal impairment	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Urethral disorder	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Renal and urinary disorders Urinary hesitation	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Reproductive system and breast disorders Prostatomegaly	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Reproductive system and breast disorders Pruritus genital	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Reproductive system and breast disorders Uterine haemorrhage	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pleurisy	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Rales	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Sinus pain	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Respiratory, thoracic and mediastinal disorders Stridor	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Actinic keratosis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Dermatitis	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Eczema	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Nail disorder	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Nail dystrophy	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Pain of skin	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Pigmentation disorder	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Rash erythematous	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Rosacea	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	11.1% 1/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Scab	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Skin and subcutaneous tissue disorders Skin lesion	4.1% 2/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Surgical and medical procedures Coronary arterial stent insertion	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	50.0% 1/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Surgical and medical procedures Tooth extraction	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Peripheral arterial occlusive disease	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Peripheral vascular disorder	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	14.3% 1/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Raynaud's phenomenon	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	5.0% 1/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.
Vascular disorders Venous occlusion	2.0% 1/49 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/7 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/9 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/20 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	0.00% 0/2 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.	9.1% 1/11 • Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow up to approximately 120.56 months) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all participants who received at least 1 dose of Axitinib under A4061008 protocol.

Additional Information

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Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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