Trial Outcomes & Findings for Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders (NCT NCT01624142)
NCT ID: NCT01624142
Last Updated: 2024-05-28
Results Overview
The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
300 participants
Primary outcome timeframe
From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.
Results posted on
2024-05-28
Participant Flow
Participants were enrolled at 43 centers in Canada, South Africa, Czech Republic, Netherlands, USA, France, Spain, Italy, Belgium, Australia, New Zealand, United Kingdom, Japan, Israel, Greece, Lebanon, Brazil, and Hong Kong between 01 June 2012 and 19 March 2015.
A total of 246 participants enrolled directly in Study 20110271 and 54 participants rolled over from Study 20110233 (NCT01588496). Results are reported separately for participants with homozygous familial hypercholesterolemia (HoFH) and non-HoFH severe familial hypercholesterolemia (FH) (ie, all those not meeting the protocol criteria for HoFH).
Participant milestones
| Measure |
HoFH
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
194
|
|
Overall Study
COMPLETED
|
74
|
178
|
|
Overall Study
NOT COMPLETED
|
32
|
16
|
Reasons for withdrawal
| Measure |
HoFH
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
|
Overall Study
Death
|
3
|
6
|
|
Overall Study
Study Closure
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
Baseline characteristics by cohort
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
240 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
47.5 years
STANDARD_DEVIATION 16.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
273 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=99 Participants
|
179 Participants
n=107 Participants
|
264 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Low-density Lipoprotein Cholesterol (LDL-C) Concentration
|
329.0 mg/dL
STANDARD_DEVIATION 136.7 • n=99 Participants
|
192.7 mg/dL
STANDARD_DEVIATION 64.6 • n=107 Participants
|
240.9 mg/dL
STANDARD_DEVIATION 116.3 • n=206 Participants
|
|
Non-high-density Lipoprotein Cholesterol (non-HDL-C) Concentration
|
350.5 mg/dL
STANDARD_DEVIATION 138.4 • n=99 Participants
|
222.1 mg/dL
STANDARD_DEVIATION 68.3 • n=107 Participants
|
267.5 mg/dL
STANDARD_DEVIATION 116.3 • n=206 Participants
|
|
Lipoprotein (a) Concentration
|
104.7 nmol/L
STANDARD_DEVIATION 100.6 • n=99 Participants
|
127.1 nmol/L
STANDARD_DEVIATION 142.8 • n=107 Participants
|
119.2 nmol/L
STANDARD_DEVIATION 129.7 • n=206 Participants
|
|
Apolipoprotein B Concentration
|
200.7 mg/dL
STANDARD_DEVIATION 69.9 • n=99 Participants
|
139.2 mg/dL
STANDARD_DEVIATION 35.6 • n=107 Participants
|
160.9 mg/dL
STANDARD_DEVIATION 58.3 • n=206 Participants
|
|
Total Cholesterol/HDL-C Ratio
|
11.473 ratio
STANDARD_DEVIATION 6.312 • n=99 Participants
|
6.055 ratio
STANDARD_DEVIATION 2.397 • n=107 Participants
|
7.970 ratio
STANDARD_DEVIATION 4.943 • n=206 Participants
|
|
Apolipoprotein B/Apoliprotein A1 Ratio
|
1.984 ratio
STANDARD_DEVIATION 0.950 • n=99 Participants
|
1.023 ratio
STANDARD_DEVIATION 0.355 • n=107 Participants
|
1.362 ratio
STANDARD_DEVIATION 0.781 • n=206 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.Population: All participants who received at least one dose of evolocumab in Study 20110271
The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Number of Participants With Adverse Events
All adverse events (AEs)
|
94 Participants
|
174 Participants
|
|
Number of Participants With Adverse Events
Adverse events ≥ grade 2
|
76 Participants
|
143 Participants
|
|
Number of Participants With Adverse Events
Adverse events ≥ grade 3
|
38 Participants
|
68 Participants
|
|
Number of Participants With Adverse Events
Adverse events ≥ grade 4
|
4 Participants
|
14 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events (SAEs)
|
29 Participants
|
57 Participants
|
|
Number of Participants With Adverse Events
AEs Leading to discontinuation of evolocumab
|
3 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
2 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
Device-related adverse events
|
6 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 4
|
-20.42 percent change
Interval -38.25 to -8.28
|
-54.95 percent change
Interval -66.67 to -44.55
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 6
|
-18.32 percent change
Interval -36.09 to -4.16
|
-67.57 percent change
Interval -79.54 to -53.93
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 8
|
-20.28 percent change
Interval -37.81 to -8.44
|
-55.03 percent change
Interval -68.58 to -42.07
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 12
|
-18.26 percent change
Interval -36.06 to -7.76
|
-57.11 percent change
Interval -68.0 to -42.8
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 16
|
-23.15 percent change
Interval -39.23 to -7.87
|
-57.53 percent change
Interval -67.99 to -44.95
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 20
|
-25.37 percent change
Interval -45.99 to -8.96
|
-57.26 percent change
Interval -67.48 to -44.68
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 24
|
-21.84 percent change
Interval -41.39 to -8.11
|
-57.10 percent change
Interval -67.05 to -43.7
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 36
|
-26.79 percent change
Interval -46.44 to -8.28
|
-56.08 percent change
Interval -68.7 to -44.47
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 48
|
-25.50 percent change
Interval -44.79 to -4.43
|
-59.67 percent change
Interval -69.14 to -47.88
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 60
|
-27.26 percent change
Interval -44.58 to -4.28
|
-57.13 percent change
Interval -68.42 to -42.65
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 72
|
-27.11 percent change
Interval -51.06 to -12.03
|
-55.73 percent change
Interval -70.52 to -42.76
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 84
|
-27.96 percent change
Interval -50.29 to -7.96
|
-56.02 percent change
Interval -68.49 to -42.18
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 96
|
-22.47 percent change
Interval -46.53 to -8.12
|
-57.10 percent change
Interval -69.53 to -41.66
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 108
|
-26.15 percent change
Interval -44.58 to -5.62
|
-60.57 percent change
Interval -69.47 to -43.15
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 120
|
-26.66 percent change
Interval -43.43 to -7.42
|
-56.76 percent change
Interval -69.48 to -41.7
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 132
|
-28.25 percent change
Interval -48.23 to -9.42
|
-55.25 percent change
Interval -68.17 to -39.89
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 144
|
-28.33 percent change
Interval -49.27 to -10.33
|
-56.48 percent change
Interval -69.26 to -40.69
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 156
|
-23.65 percent change
Interval -47.66 to -11.05
|
-55.38 percent change
Interval -69.48 to -41.03
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 168
|
-29.52 percent change
Interval -51.35 to -4.41
|
-54.77 percent change
Interval -67.16 to -36.42
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 180
|
-25.66 percent change
Interval -53.71 to -9.87
|
-54.08 percent change
Interval -71.53 to -37.55
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 192
|
-30.12 percent change
Interval -53.23 to -11.81
|
-52.19 percent change
Interval -66.79 to -33.99
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 204
|
-29.62 percent change
Interval -47.43 to -6.11
|
-59.59 percent change
Interval -70.5 to -39.06
|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Week 216
|
-32.22 percent change
Interval -46.65 to -8.97
|
-50.62 percent change
Interval -67.73 to -32.31
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 4
|
-19.62 percent change
Interval -35.54 to -7.84
|
-50.00 percent change
Interval -59.92 to -39.88
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 6
|
-18.17 percent change
Interval -33.88 to -4.29
|
-59.76 percent change
Interval -70.5 to -49.23
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 8
|
-20.29 percent change
Interval -35.94 to -9.28
|
-50.61 percent change
Interval -58.49 to -37.91
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 12
|
-17.05 percent change
Interval -32.03 to -6.99
|
-50.25 percent change
Interval -61.49 to -38.63
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 16
|
-21.73 percent change
Interval -37.81 to -7.88
|
-51.31 percent change
Interval -59.76 to -40.4
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 20
|
-24.09 percent change
Interval -43.06 to -7.76
|
-50.76 percent change
Interval -59.44 to -38.67
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 24
|
-21.88 percent change
Interval -38.81 to -9.54
|
-51.12 percent change
Interval -60.67 to -38.52
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 36
|
-22.43 percent change
Interval -44.08 to -6.22
|
-49.65 percent change
Interval -61.0 to -38.26
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 48
|
-24.08 percent change
Interval -43.47 to -3.98
|
-51.12 percent change
Interval -61.58 to -42.11
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 60
|
-24.81 percent change
Interval -42.96 to -2.67
|
-49.73 percent change
Interval -61.61 to -38.0
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 72
|
-25.88 percent change
Interval -48.21 to -9.47
|
-48.94 percent change
Interval -61.14 to -36.08
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 84
|
-21.00 percent change
Interval -42.68 to -7.45
|
-49.50 percent change
Interval -62.07 to -35.14
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 96
|
-21.10 percent change
Interval -42.84 to -7.85
|
-49.53 percent change
Interval -63.8 to -36.86
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 108
|
-24.17 percent change
Interval -43.01 to -5.69
|
-52.86 percent change
Interval -61.2 to -38.11
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 120
|
-23.21 percent change
Interval -40.37 to -6.23
|
-49.45 percent change
Interval -60.48 to -35.91
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 132
|
-26.39 percent change
Interval -40.28 to -7.19
|
-49.49 percent change
Interval -60.95 to -33.66
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 144
|
-25.38 percent change
Interval -45.55 to -8.08
|
-49.81 percent change
Interval -61.69 to -33.88
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 156
|
-22.35 percent change
Interval -45.47 to -10.5
|
-50.15 percent change
Interval -60.81 to -36.11
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 168
|
-27.97 percent change
Interval -48.82 to -4.36
|
-47.93 percent change
Interval -60.71 to -31.01
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 180
|
-26.32 percent change
Interval -49.82 to -8.62
|
-48.43 percent change
Interval -62.22 to -33.06
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 192
|
-27.61 percent change
Interval -49.49 to -9.29
|
-44.50 percent change
Interval -57.71 to -29.77
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 204
|
-27.22 percent change
Interval -45.14 to -5.73
|
-50.84 percent change
Interval -64.12 to -36.03
|
|
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Week 216
|
-31.40 percent change
Interval -42.75 to -9.67
|
-45.30 percent change
Interval -61.45 to -26.32
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a)
Week 4
|
-11.11 percent change
Interval -27.5 to 0.0
|
-20.49 percent change
Interval -39.84 to -11.61
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 6
|
-8.97 percent change
Interval -24.21 to 3.76
|
-24.42 percent change
Interval -45.95 to -9.38
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 8
|
-9.95 percent change
Interval -25.0 to 3.23
|
-21.51 percent change
Interval -39.84 to -9.09
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 12
|
-7.69 percent change
Interval -21.64 to 6.83
|
-24.40 percent change
Interval -40.28 to -9.09
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 16
|
-8.93 percent change
Interval -25.0 to 4.76
|
-23.08 percent change
Interval -38.88 to -7.62
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 20
|
-13.52 percent change
Interval -29.36 to 0.0
|
-22.21 percent change
Interval -39.34 to -5.98
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 24
|
-10.46 percent change
Interval -23.75 to 1.0
|
-25.99 percent change
Interval -41.81 to -9.09
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 36
|
-15.14 percent change
Interval -28.18 to 0.0
|
-24.26 percent change
Interval -41.3 to -7.85
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 48
|
-13.17 percent change
Interval -30.51 to 0.0
|
-26.32 percent change
Interval -41.94 to -10.49
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 60
|
-13.04 percent change
Interval -35.0 to 2.86
|
-24.05 percent change
Interval -41.97 to -7.63
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 72
|
-17.43 percent change
Interval -37.19 to 5.88
|
-24.23 percent change
Interval -43.96 to -6.81
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 84
|
-14.12 percent change
Interval -36.73 to 0.63
|
-24.12 percent change
Interval -44.05 to -8.02
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 96
|
-17.24 percent change
Interval -33.33 to 0.49
|
-31.28 percent change
Interval -47.33 to -13.34
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 108
|
-21.43 percent change
Interval -42.5 to 0.0
|
-32.44 percent change
Interval -48.65 to -12.69
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 120
|
-20.16 percent change
Interval -33.25 to 0.0
|
-31.22 percent change
Interval -45.0 to -11.4
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 132
|
-19.15 percent change
Interval -37.68 to 0.0
|
-29.32 percent change
Interval -49.82 to -12.29
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 144
|
-23.64 percent change
Interval -47.06 to 0.0
|
-30.36 percent change
Interval -48.17 to -11.92
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 156
|
-18.40 percent change
Interval -42.14 to -2.33
|
-28.10 percent change
Interval -47.35 to -9.09
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 168
|
-22.94 percent change
Interval -41.01 to -0.49
|
-23.96 percent change
Interval -45.64 to -9.09
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 180
|
-17.29 percent change
Interval -43.83 to 0.0
|
-26.23 percent change
Interval -46.01 to -8.83
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 192
|
-22.78 percent change
Interval -44.44 to 0.0
|
-20.00 percent change
Interval -37.75 to -2.44
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 204
|
-16.33 percent change
Interval -38.46 to 3.95
|
-14.29 percent change
Interval -34.38 to 10.0
|
|
Percent Change From Baseline in Lipoprotein (a)
Week 216
|
-14.06 percent change
Interval -36.07 to 4.08
|
-0.67 percent change
Interval -23.64 to 23.81
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B
Week 4
|
-16.91 percent change
Interval -31.67 to -6.81
|
-43.84 percent change
Interval -54.59 to -34.4
|
|
Percent Change From Baseline in Apolipoprotein B
Week 6
|
-16.25 percent change
Interval -27.82 to -1.96
|
-56.70 percent change
Interval -67.23 to -46.11
|
|
Percent Change From Baseline in Apolipoprotein B
Week 8
|
-17.57 percent change
Interval -32.0 to -6.24
|
-43.95 percent change
Interval -55.69 to -31.55
|
|
Percent Change From Baseline in Apolipoprotein B
Week 12
|
-13.11 percent change
Interval -26.87 to -3.49
|
-45.78 percent change
Interval -55.16 to -32.65
|
|
Percent Change From Baseline in Apolipoprotein B
Week 16
|
-18.65 percent change
Interval -34.77 to -8.35
|
-45.72 percent change
Interval -55.23 to -35.39
|
|
Percent Change From Baseline in Apolipoprotein B
Week 20
|
-22.60 percent change
Interval -39.05 to -5.03
|
-45.16 percent change
Interval -53.93 to -33.18
|
|
Percent Change From Baseline in Apolipoprotein B
Week 24
|
-20.09 percent change
Interval -33.04 to -3.97
|
-44.87 percent change
Interval -55.32 to -31.01
|
|
Percent Change From Baseline in Apolipoprotein B
Week 36
|
-16.48 percent change
Interval -36.43 to -2.56
|
-43.33 percent change
Interval -55.12 to -29.1
|
|
Percent Change From Baseline in Apolipoprotein B
Week 48
|
-15.90 percent change
Interval -33.6 to -4.15
|
-45.38 percent change
Interval -55.4 to -33.93
|
|
Percent Change From Baseline in Apolipoprotein B
Week 60
|
-15.99 percent change
Interval -38.12 to -0.27
|
-44.81 percent change
Interval -56.07 to -31.33
|
|
Percent Change From Baseline in Apolipoprotein B
Week 72
|
-20.70 percent change
Interval -42.02 to -3.17
|
-44.07 percent change
Interval -55.61 to -32.72
|
|
Percent Change From Baseline in Apolipoprotein B
Week 84
|
-19.52 percent change
Interval -35.66 to -0.09
|
-43.87 percent change
Interval -55.5 to -32.13
|
|
Percent Change From Baseline in Apolipoprotein B
Week 96
|
-15.07 percent change
Interval -36.34 to -3.67
|
-42.31 percent change
Interval -57.65 to -29.89
|
|
Percent Change From Baseline in Apolipoprotein B
Week 108
|
-19.45 percent change
Interval -36.07 to 5.03
|
-46.30 percent change
Interval -55.41 to -32.21
|
|
Percent Change From Baseline in Apolipoprotein B
Week 120
|
-21.58 percent change
Interval -33.33 to -1.57
|
-44.33 percent change
Interval -54.68 to -30.0
|
|
Percent Change From Baseline in Apolipoprotein B
Week 132
|
-22.44 percent change
Interval -35.7 to -3.75
|
-43.48 percent change
Interval -54.9 to -28.22
|
|
Percent Change From Baseline in Apolipoprotein B
Week 144
|
-21.24 percent change
Interval -41.89 to -3.55
|
-41.64 percent change
Interval -54.36 to -27.85
|
|
Percent Change From Baseline in Apolipoprotein B
Week 156
|
-18.30 percent change
Interval -36.66 to -5.63
|
-44.04 percent change
Interval -55.16 to -29.73
|
|
Percent Change From Baseline in Apolipoprotein B
Week 168
|
-20.38 percent change
Interval -41.58 to -2.81
|
-40.20 percent change
Interval -52.22 to -25.78
|
|
Percent Change From Baseline in Apolipoprotein B
Week 180
|
-19.51 percent change
Interval -39.73 to -3.02
|
-41.58 percent change
Interval -54.7 to -24.57
|
|
Percent Change From Baseline in Apolipoprotein B
Week 192
|
-19.38 percent change
Interval -39.63 to -2.63
|
-37.02 percent change
Interval -52.06 to -21.08
|
|
Percent Change From Baseline in Apolipoprotein B
Week 204
|
-21.64 percent change
Interval -36.15 to -5.48
|
-43.19 percent change
Interval -56.81 to -28.81
|
|
Percent Change From Baseline in Apolipoprotein B
Week 216
|
-22.68 percent change
Interval -35.34 to -4.51
|
-35.95 percent change
Interval -53.05 to -23.95
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 4
|
-21.32 percent change
Interval -38.45 to -10.36
|
-43.49 percent change
Interval -53.07 to -33.78
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 6
|
-23.25 percent change
Interval -35.54 to -7.14
|
-52.38 percent change
Interval -60.97 to -42.29
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 8
|
-23.93 percent change
Interval -35.26 to -5.42
|
-43.44 percent change
Interval -51.21 to -34.81
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 12
|
-21.20 percent change
Interval -34.98 to -9.31
|
-44.75 percent change
Interval -53.2 to -35.12
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 16
|
-24.01 percent change
Interval -36.52 to -8.86
|
-45.31 percent change
Interval -52.38 to -34.95
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 20
|
-24.69 percent change
Interval -36.39 to -4.29
|
-43.07 percent change
Interval -51.89 to -33.54
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 24
|
-23.53 percent change
Interval -38.59 to -9.1
|
-43.79 percent change
Interval -52.96 to -34.28
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 36
|
-27.16 percent change
Interval -42.86 to -9.12
|
-42.69 percent change
Interval -53.01 to -30.99
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 48
|
-26.54 percent change
Interval -43.73 to -8.03
|
-44.68 percent change
Interval -54.47 to -33.9
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 60
|
-22.80 percent change
Interval -45.57 to -5.13
|
-43.82 percent change
Interval -54.01 to -32.46
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 72
|
-24.79 percent change
Interval -42.72 to -9.47
|
-42.64 percent change
Interval -54.28 to -30.73
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 84
|
-22.62 percent change
Interval -41.45 to -6.24
|
-43.16 percent change
Interval -53.15 to -27.42
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 96
|
-23.00 percent change
Interval -38.97 to -10.33
|
-42.46 percent change
Interval -54.03 to -31.69
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 108
|
-25.03 percent change
Interval -41.12 to -4.98
|
-43.68 percent change
Interval -53.91 to -32.9
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 120
|
-25.40 percent change
Interval -42.55 to -6.92
|
-42.42 percent change
Interval -54.18 to -30.87
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 132
|
-25.66 percent change
Interval -41.29 to -5.1
|
-42.14 percent change
Interval -53.54 to -30.15
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 144
|
-27.79 percent change
Interval -44.96 to -6.39
|
-43.40 percent change
Interval -54.91 to -28.8
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 156
|
-25.52 percent change
Interval -45.62 to -9.87
|
-43.85 percent change
Interval -53.49 to -29.86
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 168
|
-26.30 percent change
Interval -46.28 to -8.75
|
-41.59 percent change
Interval -52.67 to -24.39
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 180
|
-29.53 percent change
Interval -47.74 to -7.54
|
-40.13 percent change
Interval -54.5 to -28.99
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 192
|
-27.79 percent change
Interval -47.16 to -12.15
|
-38.24 percent change
Interval -53.8 to -25.34
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 204
|
-27.32 percent change
Interval -42.19 to -7.2
|
-43.13 percent change
Interval -57.5 to -31.5
|
|
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio
Week 216
|
-30.92 percent change
Interval -42.09 to -8.93
|
-40.78 percent change
Interval -52.6 to -26.46
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 4
|
-23.06 percent change
Interval -39.88 to -6.22
|
-46.79 percent change
Interval -57.95 to -37.69
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 6
|
-21.38 percent change
Interval -36.9 to -10.11
|
-59.77 percent change
Interval -68.35 to -48.98
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 8
|
-21.53 percent change
Interval -36.51 to -4.66
|
-47.82 percent change
Interval -57.87 to -37.07
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 12
|
-16.67 percent change
Interval -30.72 to -4.37
|
-48.63 percent change
Interval -59.21 to -38.16
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 16
|
-22.52 percent change
Interval -42.86 to -8.97
|
-48.98 percent change
Interval -58.13 to -39.59
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 20
|
-25.41 percent change
Interval -41.87 to -12.43
|
-49.12 percent change
Interval -57.11 to -38.09
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 24
|
-22.97 percent change
Interval -38.08 to -8.99
|
-49.92 percent change
Interval -58.44 to -37.29
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 36
|
-26.86 percent change
Interval -41.04 to -7.69
|
-49.02 percent change
Interval -58.1 to -35.67
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 48
|
-25.96 percent change
Interval -43.38 to -12.26
|
-49.35 percent change
Interval -59.34 to -38.98
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 60
|
-24.31 percent change
Interval -44.46 to -6.67
|
-48.57 percent change
Interval -59.11 to -35.94
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 72
|
-23.63 percent change
Interval -45.15 to -10.89
|
-48.94 percent change
Interval -60.36 to -38.76
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 84
|
-24.09 percent change
Interval -43.12 to -4.16
|
-49.47 percent change
Interval -59.73 to -34.54
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 96
|
-24.75 percent change
Interval -45.92 to -8.61
|
-48.45 percent change
Interval -60.4 to -36.17
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 108
|
-26.03 percent change
Interval -41.27 to -4.78
|
-50.18 percent change
Interval -60.18 to -37.84
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 120
|
-26.45 percent change
Interval -44.21 to -12.32
|
-49.75 percent change
Interval -59.38 to -36.17
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 132
|
-24.26 percent change
Interval -47.15 to -7.81
|
-48.54 percent change
Interval -58.39 to -32.01
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 144
|
-28.09 percent change
Interval -48.5 to -7.81
|
-47.44 percent change
Interval -59.12 to -33.82
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 156
|
-27.21 percent change
Interval -46.95 to -12.25
|
-49.10 percent change
Interval -59.29 to -35.31
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 168
|
-32.16 percent change
Interval -47.39 to -12.53
|
-44.46 percent change
Interval -56.03 to -30.06
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 180
|
-28.70 percent change
Interval -48.45 to -9.71
|
-45.13 percent change
Interval -58.67 to -30.84
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 192
|
-27.50 percent change
Interval -50.49 to -10.22
|
-43.40 percent change
Interval -56.45 to -28.14
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 204
|
-28.04 percent change
Interval -46.84 to -12.13
|
-49.71 percent change
Interval -60.22 to -35.16
|
|
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio
Week 216
|
-28.37 percent change
Interval -41.15 to -11.76
|
-44.00 percent change
Interval -56.69 to -31.29
|
SECONDARY outcome
Timeframe: Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.
Outcome measures
| Measure |
HoFH
n=106 Participants
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 Participants
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 4
|
62.1 percentage of participants
|
98.9 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 6
|
51.8 percentage of participants
|
98.2 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 8
|
57.4 percentage of participants
|
97.9 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 12
|
56.7 percentage of participants
|
99.0 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 16
|
63.7 percentage of participants
|
97.3 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 20
|
64.4 percentage of participants
|
98.9 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 24
|
66.7 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 36
|
62.8 percentage of participants
|
97.3 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 48
|
60.2 percentage of participants
|
97.9 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 60
|
60.2 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 72
|
69.4 percentage of participants
|
94.0 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 84
|
65.9 percentage of participants
|
93.9 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 96
|
65.9 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 108
|
61.0 percentage of participants
|
96.1 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 120
|
64.6 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 132
|
61.7 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 144
|
72.2 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 156
|
68.8 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 168
|
59.2 percentage of participants
|
93.6 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 180
|
63.5 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 192
|
66.2 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 204
|
65.3 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Participants With a 15% or Greater Reduction in LDL-C
Week 216
|
70.6 percentage of participants
|
88.5 percentage of participants
|
Adverse Events
HoFH
Serious events: 29 serious events
Other events: 80 other events
Deaths: 3 deaths
Severe FH
Serious events: 57 serious events
Other events: 134 other events
Deaths: 6 deaths
Total
Serious events: 86 serious events
Other events: 214 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
HoFH
n=106 participants at risk
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 participants at risk
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
Total
n=300 participants at risk
Participants received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
2/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
4/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
7/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
11/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
3/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
3/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve disease
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiogenic shock
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
2.8%
3/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
4/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
4/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
5/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supravalvular aortic stenosis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Glaucoma
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Macular hole
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest discomfort
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
5/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
6/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Complication associated with device
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
3/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
4/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
3/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
2/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Liver function test abnormal
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Transaminases increased
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin increased
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.67%
2/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.94%
1/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic stenosis
|
2.8%
3/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
2/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
5/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.52%
1/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.33%
1/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
HoFH
n=106 participants at risk
Participants with homozygous familial hypercholesterolemia (HoFH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) levels.
|
Severe FH
n=194 participants at risk
Participants with severe (non-HoFH) familial hypercholesterolemia (FH) received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
Total
n=300 participants at risk
Participants received 420 mg evolocumab every month (participants not on lipid apheresis) or every 2 weeks (participants on lipid apheresis) for up to 5 years. Participants could switch dosing regimens at week 12 or 24 based on LDL-C and serum unbound PCSK9 levels.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
7/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
7/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
14/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
7/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.3%
22/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.7%
29/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
15/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
19/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
7.5%
8/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.8%
19/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
27/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
1.9%
2/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
10/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
12/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site bruising
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.2%
10/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
14/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site pain
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
5/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
11/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
2.8%
3/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.7%
11/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
14/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
16/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
20/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
12/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
18/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
16.0%
17/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.8%
21/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.7%
38/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
17/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.6%
36/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.7%
53/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
6.6%
7/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
7/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
14/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.0%
18/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
17/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.7%
35/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
8/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
12/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
20/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
3/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
9/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
4/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
10/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.9%
23/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.7%
29/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
9/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
17/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
26/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
15/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
19/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
6/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.4%
24/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
30/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.7%
11/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
15/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
3.8%
4/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
12/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
16/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
16.0%
17/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
16/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.0%
33/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
9.4%
10/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
10/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
5/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.2%
14/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
19/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
8.5%
9/106 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
15/194 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
24/300 • Adverse events are reported from the first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months. Deaths are reported from the first dose of study drug up to the end of study visit date.
In some cases the time frame between last dose and end of study visit was more than 30 days. Two participants in included in the all-cause mortality table died more than 30 days after last dose of study drug. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER