Trial Outcomes & Findings for Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (NCT NCT01599754)

NCT ID: NCT01599754

Last Updated: 2019-09-20

Results Overview

DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 724 participants
• Primary outcome timeframe: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
• Results posted on: 2019-09-20

Participant Flow

A total of 128 study sites in 9 countries randomized 724 participants into this study.

Participant milestones

Measure	Axitinib Participants at high risk of recurrent renal cell carcinoma (RCC) received Axitinib 5 milligram (mg) twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Study STARTED	363	361
Overall Study Treated	360	360
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	363	360

Reasons for withdrawal

Measure	Axitinib Participants at high risk of recurrent renal cell carcinoma (RCC) received Axitinib 5 milligram (mg) twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Study Anticancer therapy need not in protocol	5	2
Overall Study Participant noncompliance	4	4
Overall Study Lost to Follow-up	13	6
Overall Study Death	31	33
Overall Study Adverse Event	3	2
Overall Study Investigator decision	1	3
Overall Study Withdrawal by Subject	24	25
Overall Study Study terminated by sponsor	282	285

Baseline Characteristics

Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

Baseline characteristics by cohort

Measure	Axitinib n=363 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. .	Placebo n=361 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Total n=724 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	255 Participants n=5 Participants	247 Participants n=7 Participants	502 Participants n=5 Participants
Age, Categorical >=65 years	108 Participants n=5 Participants	114 Participants n=7 Participants	222 Participants n=5 Participants
Age, Continuous	57.9 Years STANDARD_DEVIATION 10.80 • n=5 Participants	58.1 Years STANDARD_DEVIATION 11.33 • n=7 Participants	58.0 Years STANDARD_DEVIATION 11.06 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	111 Participants n=7 Participants	194 Participants n=5 Participants
Sex: Female, Male Male	280 Participants n=5 Participants	250 Participants n=7 Participants	530 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	264 Participants n=5 Participants	267 Participants n=7 Participants	531 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	90 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment South Korea	87 participants n=5 Participants	88 participants n=7 Participants	175 participants n=5 Participants
Region of Enrollment Hong Kong	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	47 participants n=7 Participants	97 participants n=5 Participants
Region of Enrollment Japan	81 participants n=5 Participants	79 participants n=7 Participants	160 participants n=5 Participants
Region of Enrollment China	63 participants n=5 Participants	65 participants n=7 Participants	128 participants n=5 Participants
Region of Enrollment Taiwan	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants
Region of Enrollment France	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Region of Enrollment India	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Spain	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
BMI Normal Weight	187 Participants n=5 Participants	173 Participants n=7 Participants	360 Participants n=5 Participants
BMI Overweight + Obese	165 Participants n=5 Participants	175 Participants n=7 Participants	340 Participants n=5 Participants
BMI Overweight	115 Participants n=5 Participants	124 Participants n=7 Participants	239 Participants n=5 Participants
BMI Obese	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
BMI Underweight	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
BMI Missing	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)

Population: ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.

DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.

Outcome measures

Measure	Axitinib n=363 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=361 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)	NA years Interval 4.1 to Median and upper limit of CI was not estimable due to low number of participants who had event.	NA years Interval 4.1 to Median and upper limit of CI was not estimable due to low number of participants who had event.

SECONDARY outcome

Timeframe: From randomization date until death due to any cause (up to 5 years)

Population: ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.

OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.

Outcome measures

Measure	Axitinib n=363 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=361 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Survival (OS)	NA years Median, upper and lower limit of CI was not estimable due to low number of participants who had event.	NA years Median, upper and lower limit of CI was not estimable due to low number of participants who had event.

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Outcome measures

Measure	Axitinib n=360 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs) AEs	353 Participants	333 Participants
Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs) SAEs	75 Participants	54 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.

Outcome measures

Measure	Axitinib n=360 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs) Treatment Related AEs	326 Participants	202 Participants
Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs) Treatment Related SAEs	27 Participants	9 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).

Outcome measures

Measure	Axitinib n=360 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity Grade 1	23 Participants	69 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity Grade 2	108 Participants	152 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity Grade 3	208 Participants	103 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity Grade 4	12 Participants	8 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity Grade 5	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories.

Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).

Outcome measures

Measure	Axitinib n=360 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Anemia · Grade 1	256 Participants	233 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Anemia · Grade 2	87 Participants	114 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Anemia · Grade 3	8 Participants	6 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Anemia · Grade 4	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Anemia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Hemoglobin increased · Grade 1	328 Participants	354 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Hemoglobin increased · Grade 2	23 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Hemoglobin increased · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Hemoglobin increased · Grade 4	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Hemoglobin increased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count decreased · Grade 1	305 Participants	282 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count decreased · Grade 2	26 Participants	39 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count decreased · Grade 3	19 Participants	33 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count decreased · Grade 4	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count increased · Grade 1	343 Participants	339 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count increased · Grade 2	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count increased · Grade 3	8 Participants	16 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count increased · Grade 4	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Lymphocyte count increased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Neutrophil count decreased · Grade 1	284 Participants	299 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Neutrophil count decreased · Grade 2	48 Participants	45 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Neutrophil count decreased · Grade 3	19 Participants	8 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Neutrophil count decreased · Grade 4	0 Participants	3 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Neutrophil count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Platelet count decreased · Grade 1	267 Participants	303 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Platelet count decreased · Grade 2	77 Participants	49 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Platelet count decreased · Grade 3	5 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Platelet count decreased · Grade 4	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology Platelet count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology White blood cell count decreased · Grade 1	288 Participants	281 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology White blood cell count decreased · Grade 2	55 Participants	67 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology White blood cell count decreased · Grade 3	8 Participants	6 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology White blood cell count decreased · Grade 4	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology White blood cell count decreased · Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories.

Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).

Outcome measures

Measure	Axitinib n=360 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatine phosphokinase increased · Grade 1	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatine phosphokinase increased · Grade 2	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatine phosphokinase increased · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatine phosphokinase increased · Grade 4	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatine phosphokinase increased · Grade 5	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatinine increased · Grade 1	13 Participants	7 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatinine increased · Grade 2	274 Participants	301 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatinine increased · Grade 3	60 Participants	46 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatinine increased · Grade 4	3 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Creatinine increased · Grade 5	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoalbuminemia · Grade 1	347 Participants	348 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoalbuminemia · Grade 2	4 Participants	5 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoalbuminemia · Grade 3	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoalbuminemia · Grade 4	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoalbuminemia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypercalcemia · Grade 1	335 Participants	344 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypercalcemia · Grade 2	16 Participants	11 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypercalcemia · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypercalcemia · Grade 4	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypercalcemia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypocalcemia · Grade 1	280 Participants	266 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypocalcemia · Grade 2	64 Participants	85 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypocalcemia · Grade 3	3 Participants	4 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypocalcemia · Grade 4	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypocalcemia · Grade 5	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperglycemia · Grade 1	116 Participants	115 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperglycemia · Grade 2	160 Participants	159 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperglycemia · Grade 3	62 Participants	56 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperglycemia · Grade 4	12 Participants	23 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperglycemia · Grade 5	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoglycemia · Grade 1	230 Participants	246 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoglycemia · Grade 2	111 Participants	101 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoglycemia · Grade 3	9 Participants	6 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoglycemia · Grade 4	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypoglycemia · Grade 5	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperkalemia · Grade 1	318 Participants	325 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperkalemia · Grade 2	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperkalemia · Grade 3	26 Participants	21 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperkalemia · Grade 4	6 Participants	9 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyperkalemia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypokalemia · Grade 1	340 Participants	348 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypokalemia · Grade 2	9 Participants	7 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypokalemia · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypokalemia · Grade 4	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypokalemia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypernatremia · Grade 1	245 Participants	245 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypernatremia · Grade 2	96 Participants	94 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypernatremia · Grade 3	8 Participants	14 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypernatremia · Grade 4	2 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hypernatremia · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyponatremia · Grade 1	331 Participants	338 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyponatremia · Grade 2	13 Participants	11 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyponatremia · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyponatremia · Grade 4	7 Participants	5 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Hyponatremia · Grade 5	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Blood bilirubin increased · Grade 1	315 Participants	330 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Blood bilirubin increased · Grade 2	30 Participants	18 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Blood bilirubin increased · Grade 3	6 Participants	6 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Blood bilirubin increased · Grade 4	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alanine aminotransferase increased · Grade 1	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alanine aminotransferase increased · Grade 2	0 Participants	3 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alanine aminotransferase increased · Grade 3	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alanine aminotransferase increased · Grade 4	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alanine aminotransferase increased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alkaline phosphatase increased, · Grade 1	298 Participants	316 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alkaline phosphatase increased, · Grade 2	53 Participants	37 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alkaline phosphatase increased, · Grade 3	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alkaline phosphatase increased, · Grade 4	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Alkaline phosphatase increased, · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Aspartate aminotransferase increased · Grade 1	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Aspartate aminotransferase increased · Grade 2	2 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Aspartate aminotransferase increased · Grade 3	1 Participants	3 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Aspartate aminotransferase increased · Grade 4	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Aspartate aminotransferase increased · Grade 5	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry Blood bilirubin increased · Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported.

Outcome measures

Measure	Axitinib n=351 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=356 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Laboratory Abnormalities: Thyroid Function <5 mIU/L	160 Participants	308 Participants
Number of Participants With Laboratory Abnormalities: Thyroid Function >=5 - <10 mIU/L	105 Participants	37 Participants
Number of Participants With Laboratory Abnormalities: Thyroid Function >=10 mIU/L	86 Participants	11 Participants

SECONDARY outcome

Timeframe: From Day 1 up to 28 days after last dose (maximum duration of 3 years)

Population: As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.

Outcome measures

Measure	Axitinib n=351 Participants Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=355 Participants Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Number of Participants With Laboratory Abnormalities: Urinalysis Negative/trace	135 Participants	237 Participants
Number of Participants With Laboratory Abnormalities: Urinalysis 1+	88 Participants	84 Participants
Number of Participants With Laboratory Abnormalities: Urinalysis 2+	74 Participants	24 Participants
Number of Participants With Laboratory Abnormalities: Urinalysis 3+	49 Participants	8 Participants
Number of Participants With Laboratory Abnormalities: Urinalysis 4+	5 Participants	2 Participants

Adverse Events

Axitinib

Serious events: 75 serious events

Other events: 353 other events

Deaths: 31 deaths

Placebo

Serious events: 54 serious events

Other events: 332 other events

Deaths: 33 deaths

Serious adverse events

Measure	Axitinib n=360 participants at risk Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 participants at risk Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Cardiac disorders Acute Coronary Syndrome	0.83% 3/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Acute Myocardial Infarction	0.83% 3/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Angina Pectoris	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Angina Unstable	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Atrial Fibrillation	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Cardiac Failure Congestive	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Myocardial Infarction	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Cardiac disorders Stress Cardiomyopathy	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Eye disorders Cataract	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Eye disorders Retinal Haemorrhage	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Abdominal Hernia	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Abdominal Pain	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Anal Fistula	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Diarrhoea	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Enteritis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Intestinal Polyp	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Large Intestinal Stenosis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Nausea	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Oesophageal Disorder	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Pancreatic Cyst	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Pancreatitis Acute	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Small Intestinal Obstruction	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Umbilical Hernia	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Asthenia	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Inflammation	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Hepatobiliary disorders Biliary Colic	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Hepatobiliary disorders Cholangitis Acute	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Hepatobiliary disorders Cholecystitis	1.4% 5/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Hepatobiliary disorders Cholelithiasis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Hepatobiliary disorders Livery Injury	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Immune system disorders Anaphylactic Reaction	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Immune system disorders Anaphylactic Shock	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Abdominal Abscess	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Anal Abscess	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Appendicitis	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Cellulitis	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Diarrhoea Infectious	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Diverticulitis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Gastroenteritis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Herpes Zoster	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Orchitis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Otitis Externa	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Otitis Media Chronic	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Pneumonia	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Pneumonia Bacterial	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Pulmonary Tuberculosis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Pyelonephritis Acute	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Tonsillitis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Urinary Tract Infection	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Fibula Fracture	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Head Injury	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Ligament Injury	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Ligament Sprain	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Meniscus Injury	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Snake Bite	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Wound	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Dehydration	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Diabetes Mellitus	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Hyperglycaemia	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Hyperlipidaemia	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Bursitis	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Neoplasm	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's Sarcoma	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Intestine Carcinoma	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of the Oral Cavity	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Cerebral Haemorrhage	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Cerebral Infarction	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Haemorrhagic Stroke	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Intracranial Aneurysm	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Loss of Consciousness	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Myelopathy	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Psychiatric disorders Completed Suicide	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Psychiatric disorders Depression	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Psychiatric disorders Suicide Attempt	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Acute Kidney Injury	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Bladder Neck Obstruction	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Haematuria	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Nephrolithiasis	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Renal Disorder	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Ureterolithiasis	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Reproductive system and breast disorders Variococele	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Vascular disorders Aortic Intramural Haematoma	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Vascular disorders Hypertension	0.56% 2/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Vascular disorders Peripheral Artery Aneurysm	0.28% 1/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	0.00% 0/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

Other adverse events

Measure	Axitinib n=360 participants at risk Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.	Placebo n=360 participants at risk Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Investigations Weight Increased	5.0% 18/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	9.7% 35/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Endocrine disorders Hypothyroidism	20.3% 73/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.1% 22/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Abdominal Pain	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	4.7% 17/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Abdominal Pain Upper	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	2.8% 10/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Consitpation	6.7% 24/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.4% 23/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Diarrhoea	46.7% 168/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	14.4% 52/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Dyspepsia	6.1% 22/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	2.8% 10/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Nausea	10.0% 36/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	9.4% 34/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Stomatitis	12.8% 46/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	2.5% 9/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Gastrointestinal disorders Vomiting	5.6% 20/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	4.4% 16/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Asthenia	11.4% 41/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.1% 22/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Fatigue	20.8% 75/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	12.2% 44/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Malaise	5.3% 19/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	2.8% 10/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
General disorders Pyrexia	3.6% 13/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	5.3% 19/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Nasopharyngitis	15.8% 57/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	17.2% 62/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Infections and infestations Upper Respiratory Tract Infection	9.2% 33/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	8.9% 32/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Investigations Alanine Aminotransferase Increased	8.6% 31/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.6% 13/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Investigations Aspartate Aminotransferase Increased	7.8% 28/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.1% 11/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Investigations Blood Creatinine Increased	9.4% 34/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.4% 23/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Investigations Blood Thyroid Stimulating Hormone Increased	13.3% 48/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	1.4% 5/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Investigations Weight Decreased	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	1.4% 5/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Metabolism and nutrition disorders Decreased Appetite	12.5% 45/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	1.9% 7/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	16.4% 59/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	10.0% 36/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Back Pain	12.8% 46/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	15.0% 54/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	5.8% 21/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	2.8% 10/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Myalgia	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.1% 11/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Musculoskeletal and connective tissue disorders Pain In Extremity	9.7% 35/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.4% 23/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Dizziness	11.7% 42/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	9.4% 34/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Dysgeusia	6.7% 24/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	1.4% 5/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Nervous system disorders Headache	13.3% 48/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	11.1% 40/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Psychiatric disorders Insomnia	5.6% 20/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	5.0% 18/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Renal and urinary disorders Proteniurea	23.3% 84/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Cough	9.4% 34/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	7.8% 28/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Dysphonia	41.4% 149/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	5.8% 21/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 19/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.1% 11/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.1% 29/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	1.1% 4/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.6% 20/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.3% 12/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Alopecia	5.6% 20/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.1% 11/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Dry Skin	6.9% 25/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	3.9% 14/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Palmar-Plantar Ertythrodysaesthesia Syndrome	31.9% 115/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	4.7% 17/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Pruritus	6.4% 23/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	8.6% 31/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Skin and subcutaneous tissue disorders Rash	12.8% 46/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	4.2% 15/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Vascular disorders Hypertension	64.2% 231/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.	25.3% 91/360 • From Day 1 up to 28 days after last dose (maximum duration of 3 years) Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

Additional Information

Stewart Hallett

SFJ Pharmaceuticals

Phone: 19252011003

Email: stewart.hallett@sfj-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60