Trial Outcomes & Findings for Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer (NCT NCT00920816)

NCT ID: NCT00920816

Last Updated: 2022-05-06

Results Overview

Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 492 participants
• Primary outcome timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
• Results posted on: 2022-05-06

Participant Flow

First-line participants included all treatment-naive participants with metastatic renal cell cancer (mRCC) from global and second-line participants included all previously-treated Asian participants with mRCC.

All China participants were excluded from safety analysis due to inability to obtain timely approval to use data in accordance with Human Genetic Resources Administration of China (HGRAC) regulation.

Participant milestones

Measure	Axitinib (First-line Participants) Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Axitinib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Study STARTED	192	96	135	69
Overall Study Treated	189	96	135	69
Overall Study Participants From China (Excluded From Safety Analysis)	16	8	124	64
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	192	96	135	69

Reasons for withdrawal

Measure	Axitinib (First-line Participants) Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Axitinib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (Second-line Participants) Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Study Death	116	63	8	3
Overall Study Participant refused continued treatment for reason other than adverse events	11	5	1	0
Overall Study Global deterioration of health status	2	0	0	0
Overall Study Objective progression or relapse	6	2	0	0
Overall Study Other	26	15	1	2
Overall Study Lost to Follow-up	11	2	0	0
Overall Study Adverse Event	1	1	1	0
Overall Study Data not disclosed due to lack of HGRAC filings	16	8	124	64
Overall Study Randomized but not treated	3	0	0	0

Baseline Characteristics

Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Baseline characteristics by cohort

Measure	Axitinib (First-line Participants) n=192 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=96 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Axitinib (Second-line Participants) n=135 Participants Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (Second-line Participants) n=69 Participants Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Total n=492 Participants Total of all reporting groups
Age, Customized Less than (<) 65 years	142 Participants n=5 Participants	77 Participants n=7 Participants	110 Participants n=5 Participants	56 Participants n=4 Participants	385 Participants n=21 Participants
Age, Customized Greater than or equal to (>=) 65 years	50 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants	13 Participants n=4 Participants	107 Participants n=21 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants	20 Participants n=4 Participants	141 Participants n=21 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	74 Participants n=7 Participants	94 Participants n=5 Participants	49 Participants n=4 Participants	351 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.

Outcome measures

Measure	Axitinib (First-line Participants) n=192 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=96 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Progression Free Survival (PFS): First-Line Participants	10.1 months Interval 7.2 to 12.1	6.5 months Interval 4.7 to 8.3

PRIMARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.

Outcome measures

Measure	Axitinib (First-line Participants) n=135 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Progression Free Survival (PFS): Second-Line Participants	6.5 months Interval 4.7 to 9.1	4.8 months Interval 3.0 to 6.5

SECONDARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Outcome measures

Measure	Axitinib (First-line Participants) n=192 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=96 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Percentage of Participants With Objective Response (OR): First-Line Participants	32.3 percentage of participants Interval 25.7 to 39.4	14.6 percentage of participants Interval 8.2 to 23.3

SECONDARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Outcome measures

Measure	Axitinib (First-line Participants) n=135 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Percentage of Participants With Objective Response (OR): Second-Line Participants	23.7 percentage of participants Interval 16.8 to 31.8	10.1 percentage of participants Interval 4.2 to 19.8

SECONDARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Population: DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).

Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Measure	Axitinib (First-line Participants) n=62 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=14 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Duration of Response (DR): First-Line Participants	14.7 months Interval 11.0 to Upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.	14.3 months Interval 11.3 to Upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.

SECONDARY outcome

Timeframe: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Population: DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).

Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Measure	Axitinib (First-line Participants) n=32 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=7 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Duration of Response (DR): Second-Line Participants	NA months Interval 12.5 to Median and upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.	8.7 months Interval 4.1 to Upper limit of CI was not estimable because participants were still responding to medication as the study was ongoing at the time of primary completion analysis and this analysis was final.

SECONDARY outcome

Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)

Population: FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Outcome measures

Measure	Axitinib (First-line Participants) n=192 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=96 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Survival (OS): First-Line Participants	NA months Interval 18.1 to Median and upper limit of CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.	NA months Interval 18.1 to Median and upper limit of CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.

SECONDARY outcome

Timeframe: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Population: FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Outcome measures

Measure	Axitinib (First-line Participants) n=135 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Overall Survival (OS): Second-Line Participants	17.2 months Interval 14.8 to Upper limit of the CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.	18.1 months Interval 12.1 to Upper limit of the CI was not reachable as data was not matured at the time of the analysis as the study was ongoing at the time of primary completion analysis and this analysis was final.

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).

Outcome measures

Measure	Axitinib (First-line Participants) n=183 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=95 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C19 D1	43.737 units on a scale Standard Deviation 7.413	45.583 units on a scale Standard Deviation 7.366
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C14 D1	43.789 units on a scale Standard Deviation 7.985	45.459 units on a scale Standard Deviation 6.535
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C1 D1	43.869 units on a scale Standard Deviation 8.117	43.865 units on a scale Standard Deviation 6.723
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C2 D1	43.328 units on a scale Standard Deviation 7.630	43.969 units on a scale Standard Deviation 6.286
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C3 D1	43.366 units on a scale Standard Deviation 7.192	43.345 units on a scale Standard Deviation 6.878
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C4 D1	42.932 units on a scale Standard Deviation 7.566	42.926 units on a scale Standard Deviation 7.324
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C5 D1	43.211 units on a scale Standard Deviation 7.578	44.022 units on a scale Standard Deviation 6.714
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C6 D1	42.787 units on a scale Standard Deviation 8.098	42.344 units on a scale Standard Deviation 6.685
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C7 D1	42.474 units on a scale Standard Deviation 7.926	43.446 units on a scale Standard Deviation 6.931
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C8 D1	42.534 units on a scale Standard Deviation 7.510	44.077 units on a scale Standard Deviation 6.986
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C9 D1	42.778 units on a scale Standard Deviation 8.229	44.051 units on a scale Standard Deviation 7.234
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C10 D1	43.120 units on a scale Standard Deviation 7.966	44.018 units on a scale Standard Deviation 6.751
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C11 D1	43.264 units on a scale Standard Deviation 7.837	45.000 units on a scale Standard Deviation 6.130
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C12 D1	43.962 units on a scale Standard Deviation 7.243	45.318 units on a scale Standard Deviation 6.440
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C13 D1	44.141 units on a scale Standard Deviation 7.289	45.787 units on a scale Standard Deviation 6.526
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C15 D1	44.176 units on a scale Standard Deviation 8.055	45.514 units on a scale Standard Deviation 5.914
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C16 D1	44.232 units on a scale Standard Deviation 7.515	46.000 units on a scale Standard Deviation 5.651
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C17 D1	43.897 units on a scale Standard Deviation 8.456	46.400 units on a scale Standard Deviation 6.262
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C18 D1	43.761 units on a scale Standard Deviation 8.019	45.357 units on a scale Standard Deviation 6.983
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C20 D1	43.733 units on a scale Standard Deviation 7.605	44.333 units on a scale Standard Deviation 7.066
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C21 D1	45.417 units on a scale Standard Deviation 6.240	43.500 units on a scale Standard Deviation 7.687
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C22 D1	47.000 units on a scale Standard Deviation 5.985	45.833 units on a scale Standard Deviation 5.937
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants C23 D1	47.571 units on a scale Standard Deviation 6.357	45.714 units on a scale Standard Deviation 6.651
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants End of treatment	39.052 units on a scale Standard Deviation 9.109	39.524 units on a scale Standard Deviation 8.896
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants Follow-up	39.683 units on a scale Standard Deviation 11.132	40.038 units on a scale Standard Deviation 9.897

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).

Outcome measures

Measure	Axitinib (First-line Participants) n=134 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C1 D1	46.753 units on a scale Standard Deviation 6.692	47.470 units on a scale Standard Deviation 7.450
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C2 D1	46.217 units on a scale Standard Deviation 7.028	45.045 units on a scale Standard Deviation 7.478
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C3 D1	45.968 units on a scale Standard Deviation 7.237	45.684 units on a scale Standard Deviation 7.756
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C4 D1	45.060 units on a scale Standard Deviation 8.040	45.792 units on a scale Standard Deviation 7.762
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C5 D1	45.775 units on a scale Standard Deviation 7.797	46.125 units on a scale Standard Deviation 7.491
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C6 D1	45.407 units on a scale Standard Deviation 7.274	46.341 units on a scale Standard Deviation 7.213
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C7 D1	45.709 units on a scale Standard Deviation 8.263	45.053 units on a scale Standard Deviation 7.843
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C8 D1	45.169 units on a scale Standard Deviation 7.609	45.676 units on a scale Standard Deviation 9.357
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C9 D1	45.829 units on a scale Standard Deviation 7.442	45.970 units on a scale Standard Deviation 8.487
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C10 D1	45.608 units on a scale Standard Deviation 8.299	46.148 units on a scale Standard Deviation 8.156
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C11 D1	45.833 units on a scale Standard Deviation 7.599	47.227 units on a scale Standard Deviation 6.611
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C12 D1	45.797 units on a scale Standard Deviation 6.967	48.091 units on a scale Standard Deviation 6.414
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C13 D1	46.727 units on a scale Standard Deviation 7.307	47.600 units on a scale Standard Deviation 5.762
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C14 D1	47.740 units on a scale Standard Deviation 7.094	49.133 units on a scale Standard Deviation 5.235
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C15 D1	48.023 units on a scale Standard Deviation 6.297	49.308 units on a scale Standard Deviation 4.111
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C16 D1	48.184 units on a scale Standard Deviation 6.186	50.500 units on a scale Standard Deviation 3.989
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C17 D1	47.909 units on a scale Standard Deviation 6.866	49.000 units on a scale Standard Deviation 5.869
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C18 D1	48.138 units on a scale Standard Deviation 6.791	49.125 units on a scale Standard Deviation 5.139
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C19 D1	48.636 units on a scale Standard Deviation 5.206	48.571 units on a scale Standard Deviation 7.458
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C20 D1	48.810 units on a scale Standard Deviation 6.478	50.500 units on a scale Standard Deviation 4.637
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants C21 D1	50.188 units on a scale Standard Deviation 5.588	50.000 units on a scale Standard Deviation 5.177
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants End of treatment	41.432 units on a scale Standard Deviation 9.188	42.889 units on a scale Standard Deviation 8.846
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants Follow-up	35.385 units on a scale Standard Deviation 7.795	38.583 units on a scale Standard Deviation 11.556

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).

Outcome measures

Measure	Axitinib (First-line Participants) n=183 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=95 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C7 D1	28.568 units on a scale Standard Deviation 4.548	29.523 units on a scale Standard Deviation 4.051
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C1 D1	28.691 units on a scale Standard Deviation 5.392	29.653 units on a scale Standard Deviation 4.699
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C2 D1	28.728 units on a scale Standard Deviation 4.581	29.963 units on a scale Standard Deviation 3.817
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C3 D1 (	29.171 units on a scale Standard Deviation 4.093	29.750 units on a scale Standard Deviation 4.095
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C4 D1	28.577 units on a scale Standard Deviation 4.305	29.642 units on a scale Standard Deviation 4.244
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C5 D1	29.020 units on a scale Standard Deviation 4.257	30.255 units on a scale Standard Deviation 3.668
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C6 D1	28.574 units on a scale Standard Deviation 4.674	29.153 units on a scale Standard Deviation 4.009
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C9 D1	28.817 units on a scale Standard Deviation 4.665	30.186 units on a scale Standard Deviation 4.392
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C8 D1	28.557 units on a scale Standard Deviation 4.308	30.296 units on a scale Standard Deviation 3.890
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C10 D1	29.057 units on a scale Standard Deviation 4.484	30.364 units on a scale Standard Deviation 4.143
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C11 D1	29.146 units on a scale Standard Deviation 4.207	30.688 units on a scale Standard Deviation 3.926
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C12 D1	29.648 units on a scale Standard Deviation 3.752	30.727 units on a scale Standard Deviation 3.896
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C13 D1	29.545 units on a scale Standard Deviation 4.056	31.483 units on a scale Standard Deviation 3.602
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C14 D1	29.579 units on a scale Standard Deviation 4.186	31.027 units on a scale Standard Deviation 3.790
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C15 D1	29.859 units on a scale Standard Deviation 4.438	30.730 units on a scale Standard Deviation 3.724
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C16 D1	29.683 units on a scale Standard Deviation 4.242	31.515 units on a scale Standard Deviation 3.242
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C17 D1	29.564 units on a scale Standard Deviation 4.695	31.567 units on a scale Standard Deviation 3.884
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C18 D1	29.380 units on a scale Standard Deviation 4.752	31.107 units on a scale Standard Deviation 4.425
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C19 D1	29.737 units on a scale Standard Deviation 4.414	31.417 units on a scale Standard Deviation 3.911
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C20 D1	29.844 units on a scale Standard Deviation 4.527	30.762 units on a scale Standard Deviation 4.122
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C21 D1	30.889 units on a scale Standard Deviation 3.115	30.056 units on a scale Standard Deviation 4.372
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C22 D1	31.696 units on a scale Standard Deviation 3.081	31.000 units on a scale Standard Deviation 3.275
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants C23 D1	31.357 units on a scale Standard Deviation 3.388	31.143 units on a scale Standard Deviation 4.413
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants End of treatment	26.556 units on a scale Standard Deviation 5.487	26.786 units on a scale Standard Deviation 5.982
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants Follow-up	26.805 units on a scale Standard Deviation 6.373	26.769 units on a scale Standard Deviation 6.095

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).

Outcome measures

Measure	Axitinib (First-line Participants) n=134 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C1 D1	31.020 units on a scale Standard Deviation 3.986	31.489 units on a scale Standard Deviation 4.538
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C2 D1	30.600 units on a scale Standard Deviation 3.892	30.682 units on a scale Standard Deviation 3.895
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C3 D1	30.645 units on a scale Standard Deviation 3.681	30.965 units on a scale Standard Deviation 3.803
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C4 D1	30.103 units on a scale Standard Deviation 4.558	30.679 units on a scale Standard Deviation 3.980
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C5 D1	30.676 units on a scale Standard Deviation 4.271	31.063 units on a scale Standard Deviation 3.629
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C6 D1	30.731 units on a scale Standard Deviation 3.973	31.439 units on a scale Standard Deviation 4.249
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C7 D1	30.920 units on a scale Standard Deviation 4.373	30.632 units on a scale Standard Deviation 4.365
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C8 D1	30.966 units on a scale Standard Deviation 4.144	30.703 units on a scale Standard Deviation 5.195
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C9 D1	31.012 units on a scale Standard Deviation 3.783	30.667 units on a scale Standard Deviation 4.884
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C10 D1	30.986 units on a scale Standard Deviation 4.133	30.926 units on a scale Standard Deviation 4.215
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C11 D1	31.212 units on a scale Standard Deviation 4.033	32.045 units on a scale Standard Deviation 3.579
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C12 D1	31.356 units on a scale Standard Deviation 3.443	32.000 units on a scale Standard Deviation 3.338
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C13 D1	31.418 units on a scale Standard Deviation 3.775	32.100 units on a scale Standard Deviation 2.989
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C14 D1	32.100 units on a scale Standard Deviation 3.321	32.800 units on a scale Standard Deviation 2.274
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C15 D1	32.000 units on a scale Standard Deviation 2.861	32.769 units on a scale Standard Deviation 2.279
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C16 D1	31.921 units on a scale Standard Deviation 3.372	33.167 units on a scale Standard Deviation 2.167
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C17 D1	32.061 units on a scale Standard Deviation 3.344	32.800 units on a scale Standard Deviation 2.898
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C18 D1	31.931 units on a scale Standard Deviation 3.116	32.625 units on a scale Standard Deviation 2.615
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C19 D1	32.364 units on a scale Standard Deviation 2.341	32.429 units on a scale Standard Deviation 4.429
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C20 D1	31.905 units on a scale Standard Deviation 2.998	33.500 units on a scale Standard Deviation 2.168
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants C21 D1	33.125 units on a scale Standard Deviation 2.473	33.500 units on a scale Standard Deviation 2.345
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants End of treatment	28.216 units on a scale Standard Deviation 5.662	29.519 units on a scale Standard Deviation 4.661
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants Follow-up	24.692 units on a scale Standard Deviation 4.366	27.500 units on a scale Standard Deviation 6.762

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	Axitinib (First-line Participants) n=183 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=94 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C1 D1	0.710 units on a scale Standard Deviation 0.254	0.712 units on a scale Standard Deviation 0.272
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C2 D1	0.709 units on a scale Standard Deviation 0.214	0.693 units on a scale Standard Deviation 0.237
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C3 D1	0.694 units on a scale Standard Deviation 0.251	0.687 units on a scale Standard Deviation 0.261
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C4 D1	0.696 units on a scale Standard Deviation 0.235	0.668 units on a scale Standard Deviation 0.265
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C5 D1	0.708 units on a scale Standard Deviation 0.221	0.673 units on a scale Standard Deviation 0.269
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C6 D1	0.683 units on a scale Standard Deviation 0.263	0.641 units on a scale Standard Deviation 0.281
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C7 D1	0.685 units on a scale Standard Deviation 0.225	0.676 units on a scale Standard Deviation 0.255
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C8 D1	0.678 units on a scale Standard Deviation 0.274	0.717 units on a scale Standard Deviation 0.244
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C9 D1	0.704 units on a scale Standard Deviation 0.239	0.729 units on a scale Standard Deviation 0.202
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C10 D1	0.682 units on a scale Standard Deviation 0.277	0.723 units on a scale Standard Deviation 0.238
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C11 D1	0.698 units on a scale Standard Deviation 0.260	0.748 units on a scale Standard Deviation 0.199
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C12 D1	0.708 units on a scale Standard Deviation 0.227	0.742 units on a scale Standard Deviation 0.218
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C13 D1	0.708 units on a scale Standard Deviation 0.253	0.761 units on a scale Standard Deviation 0.220
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C14 D1	0.703 units on a scale Standard Deviation 0.260	0.731 units on a scale Standard Deviation 0.254
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C15 D1	0.689 units on a scale Standard Deviation 0.269	0.755 units on a scale Standard Deviation 0.225
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C16 D1	0.702 units on a scale Standard Deviation 0.244	0.775 units on a scale Standard Deviation 0.186
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C17 D1	0.706 units on a scale Standard Deviation 0.250	0.738 units on a scale Standard Deviation 0.250
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C18 D1	0.699 units on a scale Standard Deviation 0.259	0.777 units on a scale Standard Deviation 0.191
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C19 D1	0.713 units on a scale Standard Deviation 0.256	0.762 units on a scale Standard Deviation 0.261
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C20 D1	0.699 units on a scale Standard Deviation 0.261	0.710 units on a scale Standard Deviation 0.300
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C21 D1	0.712 units on a scale Standard Deviation 0.232	0.702 units on a scale Standard Deviation 0.307
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C22 D1	0.737 units on a scale Standard Deviation 0.255	0.774 units on a scale Standard Deviation 0.177
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants C23 D1	0.736 units on a scale Standard Deviation 0.275	0.789 units on a scale Standard Deviation 0.187
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants End of treatment	0.635 units on a scale Standard Deviation 0.268	0.588 units on a scale Standard Deviation 0.291
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants Follow-up	0.545 units on a scale Standard Deviation 0.434	0.618 units on a scale Standard Deviation 0.254

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	Axitinib (First-line Participants) n=134 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C1 D1	0.812 units on a scale Standard Deviation 0.225	0.831 units on a scale Standard Deviation 0.186
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C2 D1	0.769 units on a scale Standard Deviation 0.218	0.754 units on a scale Standard Deviation 0.251
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C3 D1	0.772 units on a scale Standard Deviation 0.206	0.755 units on a scale Standard Deviation 0.278
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C4 D1	0.737 units on a scale Standard Deviation 0.272	0.759 units on a scale Standard Deviation 0.211
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C5 D1	0.780 units on a scale Standard Deviation 0.203	0.768 units on a scale Standard Deviation 0.275
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C6 D1	0.767 units on a scale Standard Deviation 0.251	0.753 units on a scale Standard Deviation 0.245
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C7 D1	0.762 units on a scale Standard Deviation 0.252	0.768 units on a scale Standard Deviation 0.239
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C8 D1	0.758 units on a scale Standard Deviation 0.241	0.733 units on a scale Standard Deviation 0.339
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C9 D1	0.796 units on a scale Standard Deviation 0.203	0.794 units on a scale Standard Deviation 0.262
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C10 D1	0.768 units on a scale Standard Deviation 0.243	0.820 units on a scale Standard Deviation 0.169
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C11 D1	0.792 units on a scale Standard Deviation 0.210	0.848 units on a scale Standard Deviation 0.158
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C12 D1	0.797 units on a scale Standard Deviation 0.201	0.837 units on a scale Standard Deviation 0.157
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C13 D1	0.786 units on a scale Standard Deviation 0.217	0.814 units on a scale Standard Deviation 0.156
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C14 D1	0.833 units on a scale Standard Deviation 0.162	0.871 units on a scale Standard Deviation 0.131
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C15 D1	0.819 units on a scale Standard Deviation 0.151	0.829 units on a scale Standard Deviation 0.152
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C16 D1	0.811 units on a scale Standard Deviation 0.186	0.828 units on a scale Standard Deviation 0.142
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C17 D1	0.834 units on a scale Standard Deviation 0.158	0.865 units on a scale Standard Deviation 0.122
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C18 D1	0.830 units on a scale Standard Deviation 0.164	0.829 units on a scale Standard Deviation 0.160
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C19 D1	0.830 units on a scale Standard Deviation 0.148	0.861 units on a scale Standard Deviation 0.139
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C20 D1	0.832 units on a scale Standard Deviation 0.163	0.923 units on a scale Standard Deviation 0.129
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants C21 D1	0.859 units on a scale Standard Deviation 0.155	0.852 units on a scale Standard Deviation 0.176
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants End of treatment	0.582 units on a scale Standard Deviation 0.406	0.623 units on a scale Standard Deviation 0.296
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants Follow-up	0.429 units on a scale Standard Deviation 0.358	0.418 units on a scale Standard Deviation 0.565

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)

Population: FAS treatment-naive population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.

Outcome measures

Measure	Axitinib (First-line Participants) n=182 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=94 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C1 D1	71.181 units on a scale Standard Deviation 19.641	72.362 units on a scale Standard Deviation 16.466
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C2 D1	71.714 units on a scale Standard Deviation 16.583	72.422 units on a scale Standard Deviation 14.576
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C3 D1	72.006 units on a scale Standard Deviation 16.971	71.241 units on a scale Standard Deviation 16.252
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C4 D1	72.179 units on a scale Standard Deviation 16.980	72.086 units on a scale Standard Deviation 14.904
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C5 D1	72.451 units on a scale Standard Deviation 18.237	73.615 units on a scale Standard Deviation 14.665
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C6 D1	71.574 units on a scale Standard Deviation 18.929	69.944 units on a scale Standard Deviation 17.535
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C7 D1	71.050 units on a scale Standard Deviation 18.967	73.923 units on a scale Standard Deviation 13.998
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C8 D1	71.031 units on a scale Standard Deviation 19.081	73.183 units on a scale Standard Deviation 16.674
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C9 D1	72.690 units on a scale Standard Deviation 18.789	73.780 units on a scale Standard Deviation 16.180
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C10 D1	72.910 units on a scale Standard Deviation 19.354	72.400 units on a scale Standard Deviation 18.814
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C11 D1	72.763 units on a scale Standard Deviation 18.174	72.271 units on a scale Standard Deviation 18.512
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C12 D1	73.610 units on a scale Standard Deviation 18.275	75.295 units on a scale Standard Deviation 17.052
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C13 D1	73.030 units on a scale Standard Deviation 18.348	75.432 units on a scale Standard Deviation 17.907
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C14 D1	73.147 units on a scale Standard Deviation 17.546	75.108 units on a scale Standard Deviation 18.371
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C15 D1	74.494 units on a scale Standard Deviation 17.938	74.405 units on a scale Standard Deviation 17.650
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C16 D1	73.878 units on a scale Standard Deviation 18.289	75.818 units on a scale Standard Deviation 17.716
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C17 D1	73.090 units on a scale Standard Deviation 17.717	74.333 units on a scale Standard Deviation 18.654
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C18 D1	73.817 units on a scale Standard Deviation 17.288	75.571 units on a scale Standard Deviation 18.550
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C19 D1	72.089 units on a scale Standard Deviation 18.169	75.125 units on a scale Standard Deviation 20.919
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C20 D1	74.244 units on a scale Standard Deviation 17.044	74.190 units on a scale Standard Deviation 20.425
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C21 D1	75.694 units on a scale Standard Deviation 11.918	70.500 units on a scale Standard Deviation 21.637
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C22 D1	78.000 units on a scale Standard Deviation 12.544	73.917 units on a scale Standard Deviation 15.900
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants C23 D1	77.143 units on a scale Standard Deviation 12.697	72.571 units on a scale Standard Deviation 14.820
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants End of treatment	67.254 units on a scale Standard Deviation 19.495	67.048 units on a scale Standard Deviation 22.570
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants Follow-up	69.195 units on a scale Standard Deviation 20.366	64.885 units on a scale Standard Deviation 19.916

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)

Population: FAS previously-treated Asian population. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants evaluated for this measure at specific time point for each group respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.

Outcome measures

Measure	Axitinib (First-line Participants) n=134 Participants Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=69 Participants Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C1 D1	82.799 units on a scale Standard Deviation 13.351	82.058 units on a scale Standard Deviation 14.021
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C2 D1	81.102 units on a scale Standard Deviation 13.895	78.231 units on a scale Standard Deviation 15.823
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C3 D1	80.895 units on a scale Standard Deviation 13.387	80.534 units on a scale Standard Deviation 16.453
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C4 D1	81.138 units on a scale Standard Deviation 13.508	81.245 units on a scale Standard Deviation 14.590
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C5 D1	83.018 units on a scale Standard Deviation 12.829	80.250 units on a scale Standard Deviation 15.495
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C6 D1	82.222 units on a scale Standard Deviation 13.793	80.829 units on a scale Standard Deviation 15.091
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C7 D1	82.900 units on a scale Standard Deviation 13.287	80.868 units on a scale Standard Deviation 16.140
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C8 D1	83.382 units on a scale Standard Deviation 12.636	81.000 units on a scale Standard Deviation 14.606
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C9 D1	84.171 units on a scale Standard Deviation 11.260	83.788 units on a scale Standard Deviation 10.349
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C10 D1	83.041 units on a scale Standard Deviation 13.042	82.778 units on a scale Standard Deviation 11.440
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C11 D1	84.136 units on a scale Standard Deviation 14.231	83.000 units on a scale Standard Deviation 11.832
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C12 D1	84.305 units on a scale Standard Deviation 13.211	83.500 units on a scale Standard Deviation 12.188
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C13 D1	82.927 units on a scale Standard Deviation 17.317	83.300 units on a scale Standard Deviation 11.263
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C14 D1	86.520 units on a scale Standard Deviation 10.831	86.667 units on a scale Standard Deviation 8.715
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C15 D1	85.841 units on a scale Standard Deviation 11.783	86.462 units on a scale Standard Deviation 8.678
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C16 D1	87.579 units on a scale Standard Deviation 10.391	86.083 units on a scale Standard Deviation 8.816
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C17 D1	88.424 units on a scale Standard Deviation 10.866	84.300 units on a scale Standard Deviation 10.328
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C18 D1	86.586 units on a scale Standard Deviation 13.605	83.125 units on a scale Standard Deviation 8.839
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C19 D1	89.500 units on a scale Standard Deviation 8.684	82.143 units on a scale Standard Deviation 11.495
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C20 D1	90.333 units on a scale Standard Deviation 8.679	86.000 units on a scale Standard Deviation 9.695
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants C21 D1	90.313 units on a scale Standard Deviation 9.741	84.167 units on a scale Standard Deviation 9.704
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants End of treatment	75.568 units on a scale Standard Deviation 17.934	74.741 units on a scale Standard Deviation 17.623
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants Follow-up	58.154 units on a scale Standard Deviation 20.760	64.333 units on a scale Standard Deviation 25.564

Adverse Events

Axitinib (First-line Participants)

Serious events: 77 serious events

Other events: 161 other events

Deaths: 117 deaths

Sorafenib (First-line Participants)

Serious events: 26 serious events

Other events: 83 other events

Deaths: 63 deaths

Axitinib (Second-line Participants)

Serious events: 6 serious events

Other events: 11 other events

Deaths: 9 deaths

Sorafenib (Second-line Participants)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Measure	Axitinib (First-line Participants) n=173 participants at risk Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=88 participants at risk Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Axitinib (Second-line Participants) n=11 participants at risk Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (Second-line Participants) n=5 participants at risk Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	27.3% 3/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Angina pectoris	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Myocardial infarction	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Myocardial ischaemia	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal pain	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Anal fistula	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Diarrhoea	4.6% 8/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastritis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Oesophagitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Death	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Multiple organ dysfunction syndrome	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Disease progression	11.6% 20/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Hepatobiliary disorders Cholecystitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Hepatobiliary disorders Cholecystitis acute	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Cellulitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Gastroenteritis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Upper respiratory tract infection	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Anal abscess	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Haemoglobin decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Decreased appetite	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Back pain	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Axonal and demyelinating polyneuropathy	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Haemorrhagic stroke	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Cerebrovascular accident	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Ischaemic stroke	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Ureteric obstruction	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Cough	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Thrombocytopenia	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Acute myocardial infarction	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Atrial flutter	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Cardiac arrest	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Cardio-respiratory arrest	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal distension	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastric ulcer	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Impaired gastric emptying	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Melaena	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Nausea	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Peptic ulcer	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Proctitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Rectal haemorrhage	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Retroperitoneal haematoma	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Vomiting	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Asthenia	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Chest pain	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders General physical health deterioration	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Impaired healing	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Mucosal inflammation	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Pyrexia	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Sudden death	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Abscess	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Cholecystitis infective	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Pneumonia	2.3% 4/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Pyelonephritis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Sepsis	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Skin bacterial infection	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Tonsillitis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Urinary tract infection	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Wound infection	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Humerus fracture	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Wound dehiscence	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Dehydration	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac neoplasm unspecified	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	1.2% 2/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Cerebral haemorrhage	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Cerebral ischaemia	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Paraparesis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Spinal cord compression	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Syncope	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Dysuria	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Haematuria	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Urinary retention	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Vascular disorders Angiopathy	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Vascular disorders Hypertensive crisis	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Atrioventricular block second degree	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal pain upper	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Hip fracture	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Contusion	0.58% 1/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.

Other adverse events

Measure	Axitinib (First-line Participants) n=173 participants at risk Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (First-line Participants) n=88 participants at risk Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Axitinib (Second-line Participants) n=11 participants at risk Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.	Sorafenib (Second-line Participants) n=5 participants at risk Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator's discretion. Study medication was administered in cycles of 4 weeks.
Endocrine disorders Hypothyroidism	20.8% 36/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	27.3% 3/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal pain	9.8% 17/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 8/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	27.3% 3/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal pain upper	18.5% 32/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	8.0% 7/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Constipation	9.8% 17/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	11.4% 10/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Diarrhoea	50.9% 88/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	38.6% 34/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	54.5% 6/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	40.0% 2/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Mouth ulceration	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Nausea	22.0% 38/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	17.0% 15/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Stomatitis	11.6% 20/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	4.5% 4/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Vomiting	22.0% 38/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	12.5% 11/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Chest pain	5.2% 9/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	8.0% 7/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Fatigue	31.8% 55/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	28.4% 25/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	40.0% 2/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Pyrexia	5.2% 9/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	4.5% 4/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Nasopharyngitis	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Upper respiratory tract infection	8.1% 14/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Alanine aminotransferase increased	11.0% 19/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 8/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Aspartate aminotransferase increased	9.8% 17/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 8/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood alkaline phosphatase increased	4.0% 7/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood creatinine increased	8.1% 14/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood phosphorus decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood thyroid stimulating hormone increased	9.8% 17/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Haemoglobin decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Weight decreased	40.5% 70/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	27.3% 24/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Lipase increased	4.0% 7/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Decreased appetite	27.7% 48/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 16/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	45.5% 5/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Arthralgia	16.2% 28/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	11.4% 10/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	45.5% 5/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Back pain	16.8% 29/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	15.9% 14/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	54.5% 6/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Pain in extremity	13.3% 23/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Proteinuria	11.0% 19/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	10.2% 9/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	54.5% 6/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Cough	19.1% 33/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	15.9% 14/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Dysphonia	21.4% 37/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	11.4% 10/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.9% 24/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	12.5% 11/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Alopecia	3.5% 6/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	19.3% 17/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	23.7% 41/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	35.2% 31/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	80.0% 4/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Rash	8.7% 15/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.5% 18/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Vascular disorders Hypertension	48.0% 83/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	31.8% 28/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Anaemia	8.7% 15/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	10.2% 9/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	40.0% 2/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal distension	5.2% 9/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Dry mouth	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	1.1% 1/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Dyspepsia	7.5% 13/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Asthenia	23.7% 41/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	17.0% 15/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	45.5% 5/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 7/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Mucosal inflammation	12.1% 21/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	10.2% 9/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
General disorders Oedema peripheral	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	4.5% 4/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Amylase increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	27.3% 3/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Dizziness	8.1% 14/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	2.3% 2/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Headache	13.3% 23/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Psychiatric disorders Anxiety	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Psychiatric disorders Insomnia	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.9% 12/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Erythema	2.9% 5/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	23.9% 21/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Pruritus	4.0% 7/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	10.2% 9/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin exfoliation	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Vascular disorders Hypotension	7.5% 13/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Hyperglycaemia	3.5% 6/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Endocrine disorders Hyperthyroidism	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Flatulence	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	3.4% 3/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Anal fissure	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Cheilitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Duodenitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastric ulcer	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Gingival bleeding	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Glossodynia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Haematemesis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Haemorrhoids	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Hiatus hernia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Melaena	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Oesophagitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Oral disorder	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Toothache	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Urinary tract infection	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	4.5% 4/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Haemorrhoid infection	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Pharyngotonsillitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Rhinitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Sinusitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Tonsillitis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Infections and infestations Tooth infection	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood bicarbonate decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood bilirubin increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood calcium increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood chloride increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood cholesterol increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood lactate dehydrogenase increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood urea increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Creatinine renal clearance decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Eosinophil count increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Glomerular filtration rate decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Haematocrit increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Haemoglobin increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations International normalised ratio increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Liver function test increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	40.0% 2/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Lymphocyte percentage decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Protein total decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Tri-iodothyronine free decreased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Investigations Blood pressure increased	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Muscle spasms	1.7% 3/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	6.8% 6/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.0% 7/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	5.7% 5/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	36.4% 4/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Chronic kidney disease	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Dysuria	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Haematuria	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Renal and urinary disorders Pollakiuria	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Blister	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	18.2% 2/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Anisocytosis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Macrocytosis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Polychromasia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Dizziness exertional	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Dysaesthesia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Nervous system disorders Neuralgia	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Ear and labyrinth disorders Tinnitus	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Eye disorders Vision blurred	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Fall	5.8% 10/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Mucosal excoriation	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Reproductive system and breast disorders Breast mass	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	20.0% 1/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.
Surgical and medical procedures Haemostasis	0.00% 0/173 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/88 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	9.1% 1/11 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.	0.00% 0/5 Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety is reported for all participants excluding participants from China, who received at least 1 dose of study drug with treatment assignments designated according to actual study drug received.

Additional Information

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Results disclosure agreements

• 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.
• Publication restrictions are in place

Restriction type: OTHER