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Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

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ClinicalTrials.gov Identifier: NCT02741310
Recruitment Status : Completed
First Posted : April 18, 2016
Results First Posted : March 5, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy Subjects
Interventions Drug: Placebo
Drug: Sumatriptan
Drug: Erenumab
Enrollment 34
Recruitment Details This study was conducted at 1 center in Belgium; participants were enrolled from 22 February 2016 to 11 May 2016.
Pre-assignment Details Eligible participants were randomized on day 1 to receive either erenumab or matching placebo in a 2:1 allocation ratio.
Arm/Group Title Group A: Placebo + Sumatriptan Group B: Erenumab + Sumatriptan
Hide Arm/Group Description Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2). Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
Period Title: Overall Study
Started 12 22
Completed 10 20
Not Completed 2 2
Reason Not Completed
Sponsor Decision             2             2
Arm/Group Title Group A: Placebo + Sumatriptan Group B: Erenumab + Sumatriptan Total
Hide Arm/Group Description Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2). Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2). Total of all reporting groups
Overall Number of Baseline Participants 12 22 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 22 participants 34 participants
27.3  (8.6) 29.1  (10.3) 28.5  (9.6)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 22 participants 34 participants
18 - 24 years
6
  50.0%
9
  40.9%
15
  44.1%
25 - 55 years
6
  50.0%
13
  59.1%
19
  55.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 22 participants 34 participants
Female
4
  33.3%
6
  27.3%
10
  29.4%
Male
8
  66.7%
16
  72.7%
24
  70.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 22 participants 34 participants
Hispanic or Latino
1
   8.3%
0
   0.0%
1
   2.9%
Not Hispanic or Latino
11
  91.7%
22
 100.0%
33
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 22 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Black (or African American)
0
   0.0%
1
   4.5%
1
   2.9%
Multiple
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
White
12
 100.0%
21
  95.5%
33
  97.1%
1.Primary Outcome
Title Time-weighted Averages of Mean Arterial Pressure
Hide Description

Mean arterial pressure (MAP) is the average arterial pressure during a single cardiac cycle. MAP was calculated as diastolic blood pressure (DBP) + 0.33 * (systolic blood pressure [SBP]–DBP). Individual time-weighted average in MAP were calculated as area under the measurement-time curve from predose through 2.5 hours of MAP divided by the time period over which the measurements were made (ie, AUCmap0–2.5 hr /2.5 hours).

Data were analyzed using a linear mixed effects regression model with fixed effects for treatment and period and random effect for subject; Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).

Time Frame Days 2 and 5 from predose to 2.5 hours after sumatriptan dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and with available data.
Arm/Group Title Sumatriptan Alone Erenumab + Sumatriptan
Hide Arm/Group Description:
All participants who received placebo and sumatriptan (Group A, Parts 1 and 2 and Group B, Part 1).
All participants who received erenumab plus sumatriptan (Group B, Part 2)
Overall Number of Participants Analyzed 34 20
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
87.40  (0.98) 87.36  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan Alone, Erenumab + Sumatriptan
Comments A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.
Type of Statistical Test Other
Comments The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-2.16 to 2.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and according to the following:

Grade 1 = Mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate, minimal, local or noninvasive intervention indicated; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences, urgent intervention indicated; Grade 5 = Death related to AE.

Time Frame From the first dose of study drug (sumatriptan, placebo or erenumab) until 84 days after the last dose (89 days). Part 1 includes AEs from day 1 to predose on day 4 and Part 2 includes AEs from day 4 through day 89.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab).
Arm/Group Title Part 1 Group A: Placebo + Sumatriptan Part 1 Group B: Placebo + Sumatriptan Part 2 Group A: Placebo + Sumatriptan Part 2 Group B: Erenumab + Sumatriptan
Hide Arm/Group Description:
In Part 1 participants in Group A received a placebo IV infusion on day 1 then 12 mg SC sumatriptan on day 2.
In Part 1 participants in Group B received a placebo IV infusion on day 1 then 12 mg SC sumatriptan on day 2.
In Part 2 participants in Group A received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan on day 5.
In Part 2 participants in Group B received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan on day 5.
Overall Number of Participants Analyzed 12 22 12 22
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
11
  91.7%
19
  86.4%
9
  75.0%
17
  77.3%
Adverse event ≥ grade 2
1
   8.3%
0
   0.0%
0
   0.0%
3
  13.6%
Adverse event ≥ grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Adverse event ≥ grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serious adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AE leading to discontinuation of study drug
2
  16.7%
2
   9.1%
0
   0.0%
0
   0.0%
Fatal adverse events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan
Hide Description

Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection.

Area under the plasma concentration-time curve from time 0 to 6 hours post dose (AUC6hr) after the 2nd 6 mg dose of sumatriptan was estimated using the linear trapezoidal method. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ; 0.100 ng/mL) were set to 0 before data analysis.

Log-transformed AUC6hr was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.

Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).

Time Frame Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.
Arm/Group Title Sumatriptan Alone Erenumab + Sumatriptan
Hide Arm/Group Description:
All participants who received placebo and sumatriptan (Group A, Parts 1 and 2 and Group B, Part 1).
All participants who received erenumab plus sumatriptan (Group B, Part 2)
Overall Number of Participants Analyzed 30 20
Geometric Least Squares Mean (Standard Error)
Unit of Measure: hr*ng/mL
133.33  (1.03) 130.59  (1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan Alone, Erenumab + Sumatriptan
Comments The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.93 to 1.03
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan
Hide Description

Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection. The area under the plasma concentration-time curve from time 0 to infinity (AUCinf) after the 2nd 6 mg dose of sumatriptan was estimated as the sum of AUClast and Clast/λz where Clast is the last observed concentration and λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear decay phase. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ) (0.100 ng/mL) were set to 0 before data analysis.

Log-transformed AUCinf was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect. Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).

Time Frame Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.
Arm/Group Title Sumatriptan Alone Erenumab + Sumatriptan
Hide Arm/Group Description:
All participants who received placebo and sumatriptan (Group A, Parts 1 and 2 and Group B, Part 1).
All participants who received erenumab plus sumatriptan (Group B, Part 2)
Overall Number of Participants Analyzed 30 20
Geometric Least Squares Mean (Standard Error)
Unit of Measure: hr*ng/mL
144.32  (1.03) 144.81  (1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan Alone, Erenumab + Sumatriptan
Comments The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.96 to 1.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Sumatriptan
Hide Description

Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ) (0.100 ng/mL) were set to 0 before data analysis.

Log-transformed maximum observed plasma concentration (Cmax) was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect. Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only).

Time Frame Day 2 and day 5 at predose, 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.
Arm/Group Title Sumatriptan Alone Erenumab + Sumatriptan
Hide Arm/Group Description:
All participants who received placebo and sumatriptan (Group A, Parts 1 and 2 and Group B, Part 1).
All participants who received erenumab plus sumatriptan (Group B, Part 2)
Overall Number of Participants Analyzed 30 20
Geometric Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
83.50  (1.05) 79.00  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumatriptan Alone, Erenumab + Sumatriptan
Comments The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Squares Mean Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 90%
0.82 to 1.09
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Developed Anti-erenumab Antibodies
Hide Description

Two validated assays were used to detect the presence of anti-erenumab antibodies. All samples were first tested in an electrochemiluminescence-based bridging assay to detect antibodies capable of binding to erenumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.

Binding/neutralizing antibody positive is defined as participants with an antibody positive postbaseline results and with a negative or no result at baseline.

Time Frame Baseline and day 89
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) with a postbaseline antibody result.
Arm/Group Title Group A: Placebo + Sumatriptan Group B: Erenumab + Sumatriptan
Hide Arm/Group Description:
Participants received a placebo intravenous (IV) infusion on day 1 then 12 mg subcutaneous (SC) sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
Participants received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2 (Part 1). After a 2-day washout participants received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5 (Part 2).
Overall Number of Participants Analyzed 10 20
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibody positive
0
   0.0%
1
   5.0%
Neutralizing antibody positive
0
   0.0%
1
   5.0%
Time Frame From the first dose of study drug (sumatriptan, placebo or erenumab) until 84 days after the last dose (89 days). Part 1 includes AEs from day 1 to predose on day 4 and Part 2 includes AEs from day 4 through day 89.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Part 1 Group A: Placebo + Sumatriptan Part 1 Group B: Placebo + Sumatriptan Part 2 Group A: Placebo + Sumatriptan Part 2: Group B: Erenumab + Sumatriptan
Hide Arm/Group Description In Part 1 participants in Group A received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2. In Part 1 participants in Group B received a placebo IV infusion on day 1 then 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 2. In Part 2 participants in Group A received another placebo IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5. In part 2 participants in Group B received 140 mg erenumab IV infusion on day 4 followed by 12 mg SC sumatriptan (6 mg, followed by 6 mg at least 1 hour later) on day 5.
All-Cause Mortality
Part 1 Group A: Placebo + Sumatriptan Part 1 Group B: Placebo + Sumatriptan Part 2 Group A: Placebo + Sumatriptan Part 2: Group B: Erenumab + Sumatriptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1 Group A: Placebo + Sumatriptan Part 1 Group B: Placebo + Sumatriptan Part 2 Group A: Placebo + Sumatriptan Part 2: Group B: Erenumab + Sumatriptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/22 (0.00%)   0/10 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1 Group A: Placebo + Sumatriptan Part 1 Group B: Placebo + Sumatriptan Part 2 Group A: Placebo + Sumatriptan Part 2: Group B: Erenumab + Sumatriptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   17/22 (77.27%)   9/10 (90.00%)   17/20 (85.00%) 
Blood and lymphatic system disorders         
Leukopenia  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Cardiac disorders         
Palpitations  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders         
Nausea  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
General disorders         
Chest discomfort  1  0/12 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  1/20 (5.00%) 
Chest pain  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Discomfort  1  4/12 (33.33%)  0/22 (0.00%)  1/10 (10.00%)  0/20 (0.00%) 
Fatigue  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Feeling hot  1  1/12 (8.33%)  1/22 (4.55%)  1/10 (10.00%)  1/20 (5.00%) 
Injection site erythema  1  2/12 (16.67%)  4/22 (18.18%)  1/10 (10.00%)  2/20 (10.00%) 
Injection site swelling  1  2/12 (16.67%)  4/22 (18.18%)  1/10 (10.00%)  2/20 (10.00%) 
Injection site urticaria  1  1/12 (8.33%)  0/22 (0.00%)  0/10 (0.00%)  0/20 (0.00%) 
Infections and infestations         
Cystitis  1  1/12 (8.33%)  0/22 (0.00%)  0/10 (0.00%)  0/20 (0.00%) 
Nasopharyngitis  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Viral infection  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications         
Thermal burn  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Investigations         
Blood potassium increased  1  0/12 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/20 (0.00%) 
Blood pressure systolic increased  1  1/12 (8.33%)  1/22 (4.55%)  0/10 (0.00%)  1/20 (5.00%) 
Electrocardiogram PR prolongation  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders         
Limb discomfort  1  1/12 (8.33%)  1/22 (4.55%)  0/10 (0.00%)  0/20 (0.00%) 
Musculoskeletal chest pain  1  1/12 (8.33%)  0/22 (0.00%)  1/10 (10.00%)  0/20 (0.00%) 
Musculoskeletal discomfort  1  0/12 (0.00%)  1/22 (4.55%)  0/10 (0.00%)  4/20 (20.00%) 
Nervous system disorders         
Burning sensation  1  0/12 (0.00%)  2/22 (9.09%)  0/10 (0.00%)  1/20 (5.00%) 
Dizziness  1  0/12 (0.00%)  2/22 (9.09%)  0/10 (0.00%)  1/20 (5.00%) 
Head discomfort  1  4/12 (33.33%)  8/22 (36.36%)  3/10 (30.00%)  8/20 (40.00%) 
Headache  1  1/12 (8.33%)  3/22 (13.64%)  0/10 (0.00%)  4/20 (20.00%) 
Paraesthesia  1  4/12 (33.33%)  3/22 (13.64%)  4/10 (40.00%)  4/20 (20.00%) 
Renal and urinary disorders         
Haematuria  1  1/12 (8.33%)  1/22 (4.55%)  1/10 (10.00%)  3/20 (15.00%) 
Leukocyturia  1  1/12 (8.33%)  1/22 (4.55%)  0/10 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngeal paraesthesia  1  0/12 (0.00%)  1/22 (4.55%)  0/10 (0.00%)  1/20 (5.00%) 
Throat irritation  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Throat tightness  1  2/12 (16.67%)  1/22 (4.55%)  2/10 (20.00%)  1/20 (5.00%) 
Vascular disorders         
Raynaud's phenomenon  1  0/12 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02741310     History of Changes
Other Study ID Numbers: 20140255
2015-004537-28 ( EudraCT Number )
First Submitted: February 19, 2016
First Posted: April 18, 2016
Results First Submitted: May 24, 2018
Results First Posted: March 5, 2019
Last Update Posted: April 2, 2019