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Trial Outcomes & Findings for Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer (NCT NCT00678392)

NCT ID: NCT00678392

Last Updated: 2019-01-09

Results Overview

PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

723 participants

Primary outcome timeframe

From initiation of treatment up to follow-up period (up to 3 years)

Results posted on

2019-01-09

Participant Flow

Participant milestones

Participant milestones
Measure
Axitinib 5 mg
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Study
STARTED
361
362
Overall Study
Treated
359
355
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
361
362

Reasons for withdrawal

Reasons for withdrawal
Measure
Axitinib 5 mg
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Study
Adverse Event
0
6
Overall Study
Death
280
269
Overall Study
Lost to Follow-up
15
13
Overall Study
Objective Progression or Relapse
3
8
Overall Study
Sponsor's Decision
1
2
Overall Study
Withdrawal by Subject
4
4
Overall Study
Randomized But Not Treated
2
7
Overall Study
Other
56
53

Baseline Characteristics

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Total
n=723 Participants
Total of all reporting groups
Age, Customized
Less than (<) 65 years
238 Participants
n=5 Participants
238 Participants
n=7 Participants
476 Participants
n=5 Participants
Age, Customized
Greater than or equal to (>=) 65 years
123 Participants
n=5 Participants
124 Participants
n=7 Participants
247 Participants
n=5 Participants
Sex: Female, Male
Female
96 Participants
n=5 Participants
104 Participants
n=7 Participants
200 Participants
n=5 Participants
Sex: Female, Male
Male
265 Participants
n=5 Participants
258 Participants
n=7 Participants
523 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

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

PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Progression-Free Survival (PFS)
6.7 Months
Interval 6.3 to 8.6
4.7 Months
Interval 4.6 to 5.6

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

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

OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Survival (OS)
20.1 Months
Interval 16.7 to 23.4
19.2 Months
Interval 17.5 to 22.3

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

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

ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: \>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Objective Response Rate (ORR)
19.4 Percentage of participants
Interval 15.4 to 23.9
9.4 Percentage of participants
Interval 6.6 to 12.9

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

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

DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: \>=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Duration of Response (DR)
11.0 Months
Interval 7.4 to
The upper limit of 95 percent confidence interval was not reached at the time of data cut-off.
10.6 Months
Interval 8.8 to 11.5

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety 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 AEs.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
40.7 Percentage of participants
35.8 Percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
96.1 Percentage of participants
98.0 Percentage of participants

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety 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. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Percentage of Participants With Adverse Events (AEs) by Severity
Grade 1
3.9 Percentage of participants
3.1 Percentage of participants
Percentage of Participants With Adverse Events (AEs) by Severity
Grade 2
20.1 Percentage of participants
21.7 Percentage of participants
Percentage of Participants With Adverse Events (AEs) by Severity
Grade 3
47.6 Percentage of participants
52.4 Percentage of participants
Percentage of Participants With Adverse Events (AEs) by Severity
Grade 4
10.6 Percentage of participants
11.5 Percentage of participants
Percentage of Participants With Adverse Events (AEs) by Severity
Grade 5
13.9 Percentage of participants
9.3 Percentage of participants

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety 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 attributed to study drug in a participant who received study drug. 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. AEs included both serious and non -serious AEs.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
92.2 Percentage of participants
95.2 Percentage of participants
Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
15.3 Percentage of participants
13.8 Percentage of participants

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.

Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Neutrophils: Grade 1 (n =316, 308)
13 Participants
20 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Neutrophils: Grade 2 (n =316, 308)
4 Participants
4 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Neutrophils: Grade 3 (n =316, 308)
2 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Neutrophils: Grade 4 (n =316, 308)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Platelets: Grade 1 (n =312, 310)
47 Participants
41 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Platelets: Grade 2 (n =312, 310)
0 Participants
3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Platelets: Grade 3 (n =312, 310)
1 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Platelets: Grade 4 (n =312, 310)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
White Blood Cells: Grade 1 (n =320, 315)
32 Participants
36 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
White Blood Cells: Grade 2 (n =320, 315)
4 Participants
12 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
White Blood Cells: Grade 3 (n =320, 315)
0 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
White Blood Cells: Grade 4 (n =320, 315)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hemoglobin: Grade 1 (n =320, 316)
93 Participants
112 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hemoglobin: Grade 2 (n =320, 316)
19 Participants
41 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hemoglobin: Grade 3 (n =320, 316)
1 Participants
11 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hemoglobin: Grade 4 (n =320, 316)
0 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Lymphocytes: Grade 1 (n =317, 309)
7 Participants
7 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Lymphocytes: Grade 2 (n =317, 309)
89 Participants
93 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Lymphocytes: Grade 3 (n =317, 309)
10 Participants
11 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Lymphocytes: Grade 4 (n =317, 309)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.

Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alanine aminotransferase: Grade 4 (n =331, 313)
0 Participants
3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alkaline phosphatase: Grade 1 (n =336, 319)
88 Participants
92 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alkaline phosphatase: Grade 2 (n =336, 319)
8 Participants
15 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alkaline phosphatase: Grade 3 (n =336, 319)
4 Participants
3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alkaline phosphatase: Grade 4 (n =336, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Amylase: Grade 1 (n =338, 319)
64 Participants
76 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Amylase: Grade 2 (n =338, 319)
12 Participants
21 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Amylase: Grade 3 (n =338, 319)
7 Participants
6 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Amylase: Grade 4 (n =338, 319)
0 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Aspartate aminotransferase: Grade 1 (n =331, 311)
59 Participants
67 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Aspartate aminotransferase: Grade 2 (n =331, 311)
5 Participants
7 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bicarbonate: Grade 3 (n =314, 291)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bicarbonate: Grade 4 (n =314, 291)
1 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bilirubin: Grade 1 (n =336, 318)
16 Participants
12 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Aspartate aminotransferase: Grade 3 (n =331, 311)
1 Participants
4 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Aspartate aminotransferase: Grade 4 (n =331, 311)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bicarbonate: Grade 1 (n =314, 291)
127 Participants
115 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bicarbonate: Grade 2 (n =314, 291)
11 Participants
10 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bilirubin: Grade 2 (n =336, 318)
8 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bilirubin: Grade 3 (n =336, 318)
1 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Bilirubin: Grade 4 (n =336, 318)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Creatinine: Grade 1 (n =336, 318)
155 Participants
121 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Creatinine: Grade 2 (n =336, 318)
30 Participants
9 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alanine aminotransferase: Grade 1 (n =331, 313)
65 Participants
57 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alanine aminotransferase: Grade 2 (n =331, 313)
8 Participants
6 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Alanine aminotransferase: Grade 3 (n =331, 313)
1 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Creatinine: Grade 3 (n =336, 318)
0 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Creatinine: Grade 4 (n =336, 318)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypercalcemia: Grade 1 (n =336, 319)
92 Participants
22 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypercalcemia: Grade 2 (n =336, 319)
8 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypercalcemia: Grade 3 (n =336, 319)
1 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypercalcemia: Grade 4 (n =336, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperglycemia: Grade 1 (n =336, 319)
41 Participants
28 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperglycemia: Grade 2 (n =336, 319)
45 Participants
37 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperglycemia: Grade 3 (n =336, 319)
7 Participants
7 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperglycemia: Grade 4 (n =336, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperkalemia: Grade 1 (n =333, 314)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperkalemia: Grade 2 (n =333, 314)
42 Participants
22 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperkalemia: Grade 3 (n =333, 314)
9 Participants
8 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyperkalemia: Grade 4 (n =333, 314)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypernatremia: Grade 1 (n =338, 319)
34 Participants
23 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypernatremia: Grade 2 (n =338, 319)
19 Participants
14 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypernatremia: Grade 3 (n =338, 319)
3 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypernatremia: Grade 4 (n =338, 319)
0 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoalbuminemia: Grade 1 (n =337, 319)
37 Participants
25 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoalbuminemia: Grade 2 (n =337, 319)
11 Participants
31 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoalbuminemia: Grade 3 (n =337, 319)
1 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoalbuminemia: Grade 4 (n =337, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypocalcemia: Grade 1 (n =336, 319)
25 Participants
67 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypocalcemia: Grade 2 (n =336, 319)
4 Participants
18 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypocalcemia: Grade 3 (n =336, 319)
2 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypocalcemia: Grade 4 (n =336, 319)
1 Participants
2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoglycemia: Grade 1 (n =336, 319)
23 Participants
9 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoglycemia: Grade 2 (n =336, 319)
12 Participants
16 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoglycemia: Grade 3 (n =336, 319)
1 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypoglycemia: Grade 4 (n =336, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypokalemia: Grade 1 (n =333, 314)
22 Participants
21 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypokalemia: Grade 2 (n =333, 314)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypokalemia: Grade 3 (n =333, 314)
0 Participants
5 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypokalemia: Grade 4 (n =333, 314)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyponatremia: Grade 1 (n =338, 319)
33 Participants
27 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyponatremia: Grade 2 (n =338, 319)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyponatremia: Grade 3 (n =338, 319)
11 Participants
6 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hyponatremia: Grade 4 (n =338, 319)
1 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypophosphatemia: Grade 1 (n =336, 318)
4 Participants
8 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypophosphatemia: Grade 2 (n =336, 318)
33 Participants
99 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypophosphatemia: Grade 3 (n =336, 318)
6 Participants
51 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hypophosphatemia: Grade 4 (n =336, 318)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Lipase: Grade 1 (n =338, 319)
53 Participants
76 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Lipase: Grade 2 (n =338, 319)
22 Participants
25 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Lipase: Grade 3 (n =338, 319)
14 Participants
40 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Lipase: Grade 4 (n =338, 319)
2 Participants
7 Participants

SECONDARY outcome

Timeframe: From initiation of treatment up to follow-up period (up to 3 years)

Population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.

Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=359 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine protein: Grade 1 (n =326, 289)
105 Participants
91 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine blood/ hemoglobin: Grade 1 (n =304, 272)
45 Participants
35 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine blood/ hemoglobin: Grade 2 (n =304, 272)
1 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine blood/ hemoglobin: Grade 3 (n =304, 272)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine blood/ hemoglobin: Grade 4 (n =304, 272)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine glucose: Grade 1 (n =322, 286)
12 Participants
13 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine glucose: Grade 2 (n =322, 286)
0 Participants
3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine glucose: Grade 3 (n =322, 286)
0 Participants
0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine glucose: Grade 4 (n =322, 286)
1 Participants
1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine protein: Grade 2 (n =326, 289)
31 Participants
27 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine protein: Grade 3 (n =326, 289)
27 Participants
21 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Urine protein: Grade 4 (n =326, 289)
9 Participants
7 Participants

SECONDARY outcome

Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Population: FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.

FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Baseline (n =346, 342)
43.199 Units on a scale
Standard Deviation 8.416
43.339 Units on a scale
Standard Deviation 8.162
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 2/Day1 (n =319, 296)
42.351 Units on a scale
Standard Deviation 8.305
41.668 Units on a scale
Standard Deviation 7.696
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 3/Day1 (n =279, 246)
42.590 Units on a scale
Standard Deviation 7.729
42.424 Units on a scale
Standard Deviation 7.888
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 4/Day1 (n =257, 221)
42.791 Units on a scale
Standard Deviation 8.180
43.424 Units on a scale
Standard Deviation 7.345
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 5/Day1 (n =238, 203)
42.968 Units on a scale
Standard Deviation 8.152
42.907 Units on a scale
Standard Deviation 7.255
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 6/Day1 (n =213, 179)
42.949 Units on a scale
Standard Deviation 7.842
43.057 Units on a scale
Standard Deviation 7.724
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 7/Day1 (n =206, 158)
42.747 Units on a scale
Standard Deviation 7.621
43.578 Units on a scale
Standard Deviation 7.621
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 8/Day1 (n =177, 136)
43.580 Units on a scale
Standard Deviation 7.578
44.074 Units on a scale
Standard Deviation 7.757
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 9/Day1 (n =163, 118)
43.191 Units on a scale
Standard Deviation 8.300
44.518 Units on a scale
Standard Deviation 6.511
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 10/Day1 (n =146, 96)
43.312 Units on a scale
Standard Deviation 8.564
44.771 Units on a scale
Standard Deviation 7.155
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 11/Day1 (n =122, 85)
44.119 Units on a scale
Standard Deviation 8.306
44.438 Units on a scale
Standard Deviation 7.388
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 12/Day1 (n =110, 70)
44.517 Units on a scale
Standard Deviation 8.212
44.357 Units on a scale
Standard Deviation 7.247
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 13/Day1 (n =92, 58)
44.492 Units on a scale
Standard Deviation 7.972
45.261 Units on a scale
Standard Deviation 7.840
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 14/Day1 (n =81, 54)
44.485 Units on a scale
Standard Deviation 8.204
44.898 Units on a scale
Standard Deviation 7.495
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 15/Day1 (n =61, 38)
45.291 Units on a scale
Standard Deviation 7.095
45.053 Units on a scale
Standard Deviation 6.682
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 16/Day1 (n =52, 34)
45.217 Units on a scale
Standard Deviation 7.656
44.445 Units on a scale
Standard Deviation 7.160
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 17/Day1 (n =47, 28)
45.242 Units on a scale
Standard Deviation 7.344
44.438 Units on a scale
Standard Deviation 7.683
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 18/Day1 (n =36, 22)
44.861 Units on a scale
Standard Deviation 7.769
44.182 Units on a scale
Standard Deviation 7.228
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 19/Day1 (n =29, 14)
45.379 Units on a scale
Standard Deviation 6.662
45.026 Units on a scale
Standard Deviation 7.705
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 20/Day1 (n =20, 12)
47.050 Units on a scale
Standard Deviation 5.375
44.780 Units on a scale
Standard Deviation 6.689
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Cycle 21/Day1 (n =15, 7)
45.850 Units on a scale
Standard Deviation 5.209
44.494 Units on a scale
Standard Deviation 6.153
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
End of treatment (n=163, 191)
38.328 Units on a scale
Standard Deviation 9.472
38.457 Units on a scale
Standard Deviation 8.787
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Follow up (n =80, 110)
41.919 Units on a scale
Standard Deviation 8.318
40.028 Units on a scale
Standard Deviation 9.048

SECONDARY outcome

Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Population: FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.

FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Baseline (n =346, 341)
28.874 Units on a scale
Standard Deviation 5.187
28.975 Units on a scale
Standard Deviation 5.193
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 2/Day1 (n =319, 295)
28.211 Units on a scale
Standard Deviation 4.920
28.399 Units on a scale
Standard Deviation 5.064
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 3/Day1 (n =279, 244)
28.640 Units on a scale
Standard Deviation 4.837
28.640 Units on a scale
Standard Deviation 4.868
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 4/Day1 (n =257, 220)
28.822 Units on a scale
Standard Deviation 4.952
29.130 Units on a scale
Standard Deviation 4.322
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 5/Day1 (n =238, 202)
28.869 Units on a scale
Standard Deviation 4.880
29.007 Units on a scale
Standard Deviation 4.379
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 6/Day1 (n =213, 178)
29.159 Units on a scale
Standard Deviation 4.462
29.098 Units on a scale
Standard Deviation 4.697
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 7/Day1 (n =206, 157)
29.042 Units on a scale
Standard Deviation 4.581
29.361 Units on a scale
Standard Deviation 4.558
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 8/Day1 (n =177, 135)
29.520 Units on a scale
Standard Deviation 4.346
29.619 Units on a scale
Standard Deviation 4.386
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 9/Day1 (n =163, 117)
29.194 Units on a scale
Standard Deviation 4.937
29.884 Units on a scale
Standard Deviation 3.838
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 10/Day1 (n =146, 96)
29.343 Units on a scale
Standard Deviation 4.907
29.604 Units on a scale
Standard Deviation 3.959
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 11/Day1 (n =122, 85)
29.762 Units on a scale
Standard Deviation 4.943
29.366 Units on a scale
Standard Deviation 4.404
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 12/Day1 (n =110, 70)
29.764 Units on a scale
Standard Deviation 4.507
29.257 Units on a scale
Standard Deviation 4.299
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 13/Day1 (n =92, 58)
29.594 Units on a scale
Standard Deviation 4.205
29.666 Units on a scale
Standard Deviation 4.710
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 14/Day1 (n =81, 54)
29.711 Units on a scale
Standard Deviation 4.313
29.820 Units on a scale
Standard Deviation 4.333
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 15/Day1 (n =61, 38)
30.324 Units on a scale
Standard Deviation 3.582
29.500 Units on a scale
Standard Deviation 3.454
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 16/Day1 (n =52, 34)
30.430 Units on a scale
Standard Deviation 3.443
29.474 Units on a scale
Standard Deviation 4.146
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 17/Day1 (n =47, 28)
30.551 Units on a scale
Standard Deviation 3.331
28.737 Units on a scale
Standard Deviation 4.930
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 18/Day1 (n =36, 22)
30.194 Units on a scale
Standard Deviation 3.992
29.045 Units on a scale
Standard Deviation 4.520
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 19/Day1 (n =29, 14)
30.130 Units on a scale
Standard Deviation 3.636
29.286 Units on a scale
Standard Deviation 4.795
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 20/Day1 (n =20, 12)
31.300 Units on a scale
Standard Deviation 2.736
29.250 Units on a scale
Standard Deviation 4.025
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Cycle 21/Day1 (n =15, 7)
31.067 Units on a scale
Standard Deviation 3.173
30.143 Units on a scale
Standard Deviation 4.100
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
End of Treatment (n =163, 191)
26.288 Units on a scale
Standard Deviation 5.806
26.517 Units on a scale
Standard Deviation 5.614
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Follow up (n =80, 110)
28.263 Units on a scale
Standard Deviation 4.802
27.516 Units on a scale
Standard Deviation 5.577

SECONDARY outcome

Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Population: FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Baseline (n =347, 341)
0.732 Units on a scale
Standard Deviation 0.275 • Interval 0.275 to
0.731 Units on a scale
Standard Deviation 0.257
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 2/Day1 (n =326, 307)
0.716 Units on a scale
Standard Deviation 0.267
0.696 Units on a scale
Standard Deviation 0.237
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 3/Day1 (n =287, 248)
0.722 Units on a scale
Standard Deviation 0.243
0.709 Units on a scale
Standard Deviation 0.239
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 4/Day1 (n =262, 226)
0.730 Units on a scale
Standard Deviation 0.236
0.716 Units on a scale
Standard Deviation 0.248
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 5/Day1 (n =244, 207)
0.730 Units on a scale
Standard Deviation 0.237
0.711 Units on a scale
Standard Deviation 0.243
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 6/Day1 (n =221, 178)
0.734 Units on a scale
Standard Deviation 0.230
0.704 Units on a scale
Standard Deviation 0.246
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 7/Day1 (n =213, 163)
0.718 Units on a scale
Standard Deviation 0.267
0.728 Units on a scale
Standard Deviation 0.228
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 8/Day1 (n =181, 136)
0.756 Units on a scale
Standard Deviation 0.236
0.702 Units on a scale
Standard Deviation 0.259
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 9/Day1 (n =169, 120)
0.760 Units on a scale
Standard Deviation 0.227
0.730 Units on a scale
Standard Deviation 0.229
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 10/Day1 (n =151, 98)
0.734 Units on a scale
Standard Deviation 0.243
0.730 Units on a scale
Standard Deviation 0.233
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 11/Day1 (n =126, 87)
0.764 Units on a scale
Standard Deviation 0.235
0.724 Units on a scale
Standard Deviation 0.250
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 12/Day1 (n =110, 73)
0.744 Units on a scale
Standard Deviation 0.244
0.734 Units on a scale
Standard Deviation 0.232
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 13/Day1 (n =96, 61)
0.760 Units on a scale
Standard Deviation 0.211
0.753 Units on a scale
Standard Deviation 0.232
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 14/Day1 (n =80, 57)
0.723 Units on a scale
Standard Deviation 0.239
0.752 Units on a scale
Standard Deviation 0.211
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 15/Day1 (n =63, 41)
0.730 Units on a scale
Standard Deviation 0.255
0.758 Units on a scale
Standard Deviation 0.191
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 16/Day1 (n =54, 37)
0.749 Units on a scale
Standard Deviation 0.220
0.785 Units on a scale
Standard Deviation 0.158
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 17/Day1 (n =48, 29)
0.779 Units on a scale
Standard Deviation 0.186
0.764 Units on a scale
Standard Deviation 0.193
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 18/Day1 (n =37, 20)
0.755 Units on a scale
Standard Deviation 0.204
0.755 Units on a scale
Standard Deviation 0.208
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 19/Day1 (n =29, 14)
0.734 Units on a scale
Standard Deviation 0.253
0.804 Units on a scale
Standard Deviation 0.184
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 20/Day1 (n =21, 12)
0.794 Units on a scale
Standard Deviation 0.220
0.771 Units on a scale
Standard Deviation 0.182
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Cycle 21/Day1 (n =16, 7)
0.700 Units on a scale
Standard Deviation 0.273
0.771 Units on a scale
Standard Deviation 0.182
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
End of Treatment (n =169, 196)
0.608 Units on a scale
Standard Deviation 0.316
0.612 Units on a scale
Standard Deviation 0.310
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score
Follow up (n =76, 106)
0.682 Units on a scale
Standard Deviation 0.294
0.666 Units on a scale
Standard Deviation 0.295

SECONDARY outcome

Timeframe: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Population: FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.

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

Outcome measures

Outcome measures
Measure
Axitinib 5 mg
n=361 Participants
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=362 Participants
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Baseline (n =341, 339)
70.560 Units on a scale
Standard Deviation 19.187 • Interval 0.275 to
70.351 Units on a scale
Standard Deviation 17.403
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 2/Day1 (n =317, 302)
69.003 Units on a scale
Standard Deviation 20.195
67.606 Units on a scale
Standard Deviation 18.265
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 3/Day1 (n =280, 250)
69.843 Units on a scale
Standard Deviation 17.927
69.712 Units on a scale
Standard Deviation 18.429
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 4/Day1 (n =261, 224)
69.180 Units on a scale
Standard Deviation 18.636
70.759 Units on a scale
Standard Deviation 17.189
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 5/Day1 (n =244, 205)
69.705 Units on a scale
Standard Deviation 18.330
71.888 Units on a scale
Standard Deviation 16.999
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 6/Day1 (n =220, 178)
69.900 Units on a scale
Standard Deviation 18.168
71.365 Units on a scale
Standard Deviation 17.019
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 7/Day1 (n =209, 163)
69.919 Units on a scale
Standard Deviation 18.063
72.282 Units on a scale
Standard Deviation 17.521
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 8/Day1 (n =180, 139)
70.756 Units on a scale
Standard Deviation 19.183
71.475 Units on a scale
Standard Deviation 18.523
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 9/Day1 (n =168, 121)
70.667 Units on a scale
Standard Deviation 18.556
73.380 Units on a scale
Standard Deviation 17.473
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 10/Day1 (n =151, 98)
70.629 Units on a scale
Standard Deviation 18.680
75.102 Units on a scale
Standard Deviation 14.854
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 11/Day1 (n =126, 87)
72.103 Units on a scale
Standard Deviation 18.064
74.586 Units on a scale
Standard Deviation 15.161
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 12/Day1 (n =111, 73)
71.730 Units on a scale
Standard Deviation 17.276
73.959 Units on a scale
Standard Deviation 15.852
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 13/Day1 (n =94, 61)
70.723 Units on a scale
Standard Deviation 19.147
75.693 Units on a scale
Standard Deviation 14.571
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 14/Day1 (n =81, 58)
69.420 Units on a scale
Standard Deviation 20.286
75.362 Units on a scale
Standard Deviation 15.875
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 15/Day1 (n =62, 42)
73.016 Units on a scale
Standard Deviation 15.325
75.357 Units on a scale
Standard Deviation 15.368
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 16/Day1 (n =52, 37)
70.269 Units on a scale
Standard Deviation 19.272
73.676 Units on a scale
Standard Deviation 15.699
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 17/Day1 (n =48, 30)
71.375 Units on a scale
Standard Deviation 17.840
73.767 Units on a scale
Standard Deviation 16.298
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 18/Day1 (n =37, 23)
70.459 Units on a scale
Standard Deviation 18.853
73.870 Units on a scale
Standard Deviation 16.904
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 19/Day1 (n =29, 14)
71.034 Units on a scale
Standard Deviation 16.963
70.571 Units on a scale
Standard Deviation 17.956
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 20/Day1 (n =21, 12)
73.143 Units on a scale
Standard Deviation 15.347
66.917 Units on a scale
Standard Deviation 17.758
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Cycle 21/Day1 (n =16, 7)
74.563 Units on a scale
Standard Deviation 16.054
64.714 Units on a scale
Standard Deviation 16.183
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
End of Treatment (n =166, 197)
61.759 Units on a scale
Standard Deviation 21.668
61.690 Units on a scale
Standard Deviation 20.973
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Follow up (n =76, 109)
64.382 Units on a scale
Standard Deviation 21.392
66.037 Units on a scale
Standard Deviation 19.754

Adverse Events

Axitinib 5 mg

Serious events: 146 serious events
Other events: 337 other events
Deaths: 0 deaths

Sorafenib 400 mg

Serious events: 127 serious events
Other events: 346 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Axitinib 5 mg
n=359 participants at risk
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 participants at risk
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Blood and lymphatic system disorders
Anaemia
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
2.3%
8/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Blood and lymphatic system disorders
Splenic infarction
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Acute coronary syndrome
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Acute myocardial infarction
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Angina pectoris
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Arrhythmia supraventricular
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Arteriosclerosis coronary artery
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Atrial fibrillation
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Atrial flutter
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Atrioventricular block
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Bradycardia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Cardiac arrest
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Cardiac failure
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Cardiopulmonary failure
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Congestive cardiomyopathy
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Coronary artery insufficiency
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Haemorrhage coronary artery
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Mitral valve incompetence
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Myocardial infarction
1.7%
6/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.1%
4/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Myocardial ischaemia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Prinzmetal angina
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Supraventricular tachycardia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Cardiac disorders
Tachycardia
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Endocrine disorders
Adrenal insufficiency
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Endocrine disorders
Hypothyroidism
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Endocrine disorders
Secondary hypothyroidism
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Endocrine disorders
Thyroiditis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Eye disorders
Diplopia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Eye disorders
Retinal artery embolism
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Eye disorders
Retinal artery occlusion
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Eye disorders
Retinal vein occlusion
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Eye disorders
Retinal vein thrombosis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Abdominal pain
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Anal fistula
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Ascites
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Colitis ulcerative
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Constipation
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Diarrhoea
2.2%
8/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.4%
5/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Duodenal ulcer haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Enterocolitis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Gastric haemorrhage
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Gastric ulcer
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Gastritis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.4%
5/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Gastrointestinal perforation
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Haematemesis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Inguinal hernia
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Intestinal obstruction
1.1%
4/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Melaena
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Nausea
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Pancreatitis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Retroperitoneal haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Small intestinal obstruction
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Subileus
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Vomiting
1.4%
5/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Asthenia
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Chest pain
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Chills
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Death
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.7%
6/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Device dislocation
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Disease progression
8.9%
32/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.1%
18/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Fatigue
1.1%
4/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
General physical health deterioration
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.4%
5/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Hernia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Impaired healing
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Inflammation
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Malaise
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Mucosal inflammation
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Oedema
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Pain
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.85%
3/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Pyrexia
1.9%
7/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.4%
5/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Biliary dilatation
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Budd-Chiari syndrome
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Cholangitis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Cholecystitis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Immune system disorders
Hypersensitivity
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Abdominal abscess
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Appendicitis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Aspergillus infection
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Bacterial diarrhoea
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Cellulitis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Diverticulitis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Erysipelas
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Gastroenteritis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Gastroenteritis viral
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Herpes zoster
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Infection
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Intervertebral discitis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Lower respiratory tract infection
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.1%
4/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Lower respiratory tract infection bacterial
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Lung infection
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Muscle abscess
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Pneumonia
1.4%
5/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.1%
4/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Pneumonia streptococcal
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Pneumonia viral
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Pulmonary tuberculosis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Pyelonephritis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Respiratory tract infection
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Sepsis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Septic shock
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Urinary tract infection
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Fall
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Femoral neck fracture
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Neutrophil count abnormal
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Decreased appetite
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Dehydration
2.8%
10/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hypercalcaemia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hyperkalaemia
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hypoglycaemia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hypokalaemia
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hyponatraemia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.85%
3/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Hypovolaemia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Arthralgia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Back pain
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Polyarthritis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Aphasia
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Balance disorder
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Central nervous system haemorrhage
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Cerebral infarction
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Cerebral ischaemia
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Cerebrovascular accident
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Dizziness
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Headache
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Hemiparesis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Ischaemic stroke
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Leukoencephalopathy
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Loss of consciousness
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Meningeal disorder
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Monoplegia
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Presyncope
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Seizure
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Spinal cord compression
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Syncope
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Transient ischaemic attack
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Psychiatric disorders
Anxiety
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Psychiatric disorders
Confusional state
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Psychiatric disorders
Disorientation
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Psychiatric disorders
Mental status changes
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Acute kidney injury
1.1%
4/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Acute prerenal failure
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Haematuria
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Nephropathy
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Oliguria
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Renal failure
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Urinary retention
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.38%
1/265 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/258 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Reproductive system and breast disorders
Menometrorrhagia
0.00%
0/96 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.96%
1/104 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Reproductive system and breast disorders
Vaginal polyp
1.0%
1/96 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/104 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.9%
7/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.85%
3/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.84%
3/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.4%
5/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
1.1%
4/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.9%
7/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.85%
3/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Pustular psoriasis
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Urticaria
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Surgical and medical procedures
Pain management
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Surgical and medical procedures
Vertebroplasty
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Accelerated hypertension
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Deep vein thrombosis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Hypertension
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.56%
2/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Hypertensive crisis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Hypotension
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.1%
4/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Infarction
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Jugular vein thrombosis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Subclavian vein thrombosis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Humerus fracture
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Laceration
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Procedural pain
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Radiation pneumonitis
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Soft tissue injury
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Injury, poisoning and procedural complications
Spinal compression fracture
0.28%
1/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.00%
0/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Alanine aminotransferase increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Aspartate aminotransferase increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Blood alkaline phosphatase increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Blood creatinine increased
0.56%
2/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
C-reactive protein increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Hepatic enzyme increased
0.00%
0/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
0.28%
1/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.

Other adverse events

Other adverse events
Measure
Axitinib 5 mg
n=359 participants at risk
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg
n=355 participants at risk
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Blood and lymphatic system disorders
Anaemia
5.0%
18/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
12.4%
44/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Endocrine disorders
Hypothyroidism
20.6%
74/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
9.3%
33/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Abdominal pain
15.3%
55/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
13.0%
46/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Abdominal pain upper
10.3%
37/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
4.5%
16/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Constipation
22.0%
79/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
23.1%
82/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Diarrhoea
57.9%
208/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
54.9%
195/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Dyspepsia
10.9%
39/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
4.2%
15/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Flatulence
5.6%
20/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
2.3%
8/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Nausea
35.7%
128/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
23.7%
84/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Stomatitis
16.7%
60/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
13.2%
47/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Gastrointestinal disorders
Vomiting
26.5%
95/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
19.4%
69/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Asthenia
21.7%
78/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
16.1%
57/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Chest pain
6.4%
23/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.6%
20/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Fatigue
42.1%
151/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
34.4%
122/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Mucosal inflammation
17.0%
61/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
12.7%
45/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Oedema peripheral
6.1%
22/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
6.2%
22/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Pain
5.3%
19/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
4.8%
17/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
General disorders
Pyrexia
7.2%
26/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
11.3%
40/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Infections and infestations
Nasopharyngitis
7.0%
25/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
3.7%
13/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Blood thyroid stimulating hormone increased
5.3%
19/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
3.1%
11/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Lipase increased
3.6%
13/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
6.2%
22/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Investigations
Weight decreased
30.9%
111/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
23.4%
83/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Decreased appetite
39.0%
140/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
31.5%
112/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Metabolism and nutrition disorders
Dehydration
5.0%
18/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
2.8%
10/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Arthralgia
17.3%
62/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
13.0%
46/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Back pain
16.4%
59/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
15.2%
54/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Muscle spasms
3.1%
11/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.9%
21/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
7.8%
28/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
7.6%
27/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Myalgia
7.8%
28/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
3.4%
12/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Musculoskeletal and connective tissue disorders
Pain in extremity
13.6%
49/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
14.9%
53/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Dizziness
9.2%
33/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.9%
21/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Dysgeusia
12.0%
43/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
8.7%
31/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Nervous system disorders
Headache
15.3%
55/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
12.1%
43/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Psychiatric disorders
Insomnia
9.2%
33/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.9%
21/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Renal and urinary disorders
Proteinuria
13.6%
49/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
9.0%
32/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Cough
18.9%
68/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
19.7%
70/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Dysphonia
32.3%
116/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
13.8%
49/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.8%
64/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
14.9%
53/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
5.0%
18/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
3.1%
11/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Epistaxis
7.8%
28/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.4%
19/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
2.2%
8/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.1%
18/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
6.1%
22/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
5.9%
21/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Alopecia
5.0%
18/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
34.4%
122/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Dry skin
10.0%
36/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
11.8%
42/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Erythema
3.3%
12/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
11.0%
39/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
27.9%
100/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
51.5%
183/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Pruritus
7.0%
25/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
13.5%
48/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Skin and subcutaneous tissue disorders
Rash
14.8%
53/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
30.7%
109/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Hypertension
43.5%
156/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
30.1%
107/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
Vascular disorders
Hypotension
5.3%
19/359 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
1.7%
6/355 • From initiation of treatment up to follow-up period (up to 3 years)
Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Results disclosure agreements

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

Restriction type: OTHER