Trial Outcomes & Findings for Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment (NCT NCT02585895)
NCT ID: NCT02585895
Last Updated: 2022-11-30
Results Overview
Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4: participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was \< 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group. Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Week 5 and week 6
Results posted on
2022-11-30
Participant Flow
This study was conducted at 15 centers in the following 8 countries: Australia, Czech Republic, France, Germany, Italy, Spain, the United Kingdom, and the United States. Participants were enrolled from 21 December 2015 to 21 July 2016.
Participants were randomized in a 1:1 ratio to continue apheresis on the same schedule as before study entry, or to stop apheresis and receive evolocumab. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C) (\< 160 mg/dL \[4.1 mmol/L\] vs ≥ 160 mg/dL).
Participant milestones
| Measure |
Apheresis
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
|---|---|---|
|
Primary Period
STARTED
|
20
|
19
|
|
Primary Period
COMPLETED
|
20
|
19
|
|
Primary Period
NOT COMPLETED
|
0
|
0
|
|
Post-primary Period
STARTED
|
20
|
19
|
|
Post-primary Period
COMPLETED
|
20
|
19
|
|
Post-primary Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
Baseline characteristics by cohort
| Measure |
Apheresis
n=20 Participants
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
n=19 Participants
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Age, Customized
< 65 years
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Stratification Factor: Screening LDL-C Level
< 160 mg/dL
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Stratification Factor: Screening LDL-C Level
≥ 160 mg/dL
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
LDL-C Concentration
|
150.6 mg/dL
STANDARD_DEVIATION 25.6 • n=5 Participants
|
152.4 mg/dL
STANDARD_DEVIATION 21.2 • n=7 Participants
|
151.5 mg/dL
STANDARD_DEVIATION 23.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 5 and week 6Population: All randomized participants
Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4: participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was \< 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group. Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.
Outcome measures
| Measure |
Apheresis
n=20 Participants
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
n=19 Participants
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
|---|---|---|
|
Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy
|
10.0 percentage of participants
Interval 2.8 to 30.1
|
84.2 percentage of participants
Interval 62.4 to 94.5
|
SECONDARY outcome
Timeframe: Baseline and week 4Population: Randomized participants with non-missing data
Outcome measures
| Measure |
Apheresis
n=19 Participants
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
n=19 Participants
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol
|
2.61 percent change
Standard Error 3.97
|
-50.13 percent change
Standard Error 4.03
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Randomized participants with non-missing data
Outcome measures
| Measure |
Apheresis
n=19 Participants
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
n=19 Participants
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
|---|---|---|
|
Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol
|
1.80 percent change
Standard Error 3.29
|
-44.58 percent change
Standard Error 3.34
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Randomized participants with non-missing data
Outcome measures
| Measure |
Apheresis
n=19 Participants
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
Evolocumab
n=19 Participants
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio
|
0.15 percent change
Standard Error 2.65
|
-35.65 percent change
Standard Error 2.67
|
Adverse Events
Primary Period: Apheresis QW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Primary Period: Apheresis Q2W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Primary Period: Evolocumab
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Post-primary Period: Apheresis/Evolocumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Post-primary Period: Evolocumab/Evolocumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Period: Apheresis QW
n=4 participants at risk
Participants received apheresis every week (QW) for 6 weeks during the primary period of the study.
|
Primary Period: Apheresis Q2W
n=16 participants at risk
Participants received apheresis every 2 weeks (Q2W) for 6 weeks during the primary period of the study.
|
Primary Period: Evolocumab
n=19 participants at risk
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study.
|
Post-primary Period: Apheresis/Evolocumab
n=20 participants at risk
Starting at week 6 participants received 140 mg evolocumab Q2W up to week 24.
|
Post-primary Period: Evolocumab/Evolocumab
n=19 participants at risk
Participants received 140 mg evolocumab Q2W from week 6 to week 24.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Primary Period: Apheresis QW
n=4 participants at risk
Participants received apheresis every week (QW) for 6 weeks during the primary period of the study.
|
Primary Period: Apheresis Q2W
n=16 participants at risk
Participants received apheresis every 2 weeks (Q2W) for 6 weeks during the primary period of the study.
|
Primary Period: Evolocumab
n=19 participants at risk
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study.
|
Post-primary Period: Apheresis/Evolocumab
n=20 participants at risk
Starting at week 6 participants received 140 mg evolocumab Q2W up to week 24.
|
Post-primary Period: Evolocumab/Evolocumab
n=19 participants at risk
Participants received 140 mg evolocumab Q2W from week 6 to week 24.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Mastitis
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth abscess
|
25.0%
1/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
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 complication
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.2%
1/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
2/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
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
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
25.0%
1/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
2/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
2/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Menopause
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
1/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/16 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/19 • 6 weeks during the primary period and 20 weeks during the post-primary period.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
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