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Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT01444417
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : January 19, 2017
Last Update Posted : February 9, 2017
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
Conditions Idiopathic Thrombocytopenic Purpura
Thrombocytopenia
Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenic Purpura
Immune Thrombocytopenia
Interventions Drug: Romiplostim
Drug: Placebo
Enrollment 62

Recruitment Details This study was conducted at 27 centers in the United States, Canada, and Australia. Participants were enrolled from 24 January 2012 to 03 September 2014.
Pre-assignment Details Participants who met eligibility criteria were enrolled and stratified by the following 3 age categories: ≥ 1 to < 6 years; 6 to < 12 years; and 12 to < 18 years.
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description Participants received weekly subcutaneous placebo for 24 weeks. Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Period Title: Overall Study
Started 20 42
Received Treatment 19 42
Completed 18 41
Not Completed 2 1
Reason Not Completed
Ineligibility Determined             0             1
Withdrawal by Subject             2             0
Arm/Group Title Placebo Romiplostim Total
Hide Arm/Group Description Participants received weekly subcutaneous placebo for 24 weeks. Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Total of all reporting groups
Overall Number of Baseline Participants 20 42 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 42 participants 62 participants
9.4  (4.7) 9.7  (4.1) 9.6  (4.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 42 participants 62 participants
≥ 1 - < 6 years 4 8 12
≥ 6 - < 12 years 9 18 27
≥ 12 - < 18 years 7 16 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 42 participants 62 participants
Female
11
  55.0%
24
  57.1%
35
  56.5%
Male
9
  45.0%
18
  42.9%
27
  43.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 42 participants 62 participants
American Indian or Alaska Native 0 0 0
Asian 2 3 5
Black or African American 2 6 8
Multiple 0 1 1
Native Hawaiian or Other Pacific Islander 0 1 1
Other 1 5 6
White 15 26 41
Platelets  
Mean (Standard Deviation)
Unit of measure:  10^9/L
Number Analyzed 20 participants 42 participants 62 participants
19.9  (19.3) 17.5  (10.7) 18.3  (13.9)
1.Primary Outcome
Title Percentage of Participants With a Durable Platelet Response
Hide Description A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.
Time Frame Week 18 to week 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set (all randomized participants)
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 20 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.0
(1.2 to 31.7)
52.4
(36.4 to 68.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Romiplostim
Comments The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.0497
Confidence Interval (2-Sided) 95%
1.896 to 43.199
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With an Overall Platelet Response
Hide Description

Overall platelet response is defined as either a durable platelet response or transient platelet response.

Durable platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 6 or more times during week 18 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medication.

Transient platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 4 or more times during week 2 to week 25 measurements but without durable platelet response. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.

Time Frame Week 2 to week 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 20 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.0
(5.7 to 43.7)
71.4
(55.4 to 84.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Romiplostim
Comments The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.0443
Confidence Interval (2-Sided) 95%
2.535 to 32.265
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Weeks With Platelet Response
Hide Description Number of weeks with platelet counts ≥ 50 x 10^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.
Time Frame Week 2 to week 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 20 42
Median (Full Range)
Unit of Measure: weeks
1.0
(0 to 22)
12.0
(0 to 24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Romiplostim
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANOVA
Comments P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).
4.Secondary Outcome
Title Percentage of Participants Who Received Rescue Medication During the Treatment Period
Hide Description Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 20 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.0
(23.1 to 68.5)
40.5
(25.6 to 56.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Romiplostim
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7103
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value from Cochran-Mantel-Haenszel test stratified by baseline age group
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.813
Confidence Interval (2-Sided) 95%
0.277 to 2.391
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Total Number of Composite Bleeding Episodes
Hide Description A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.
Time Frame Week 2 to week 25
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 20 42
Mean (Standard Deviation)
Unit of Measure: bleeding episodes
4.0  (6.9) 1.9  (4.2)
6.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:

  • fatal,
  • life threatening (places the subject at immediate risk of death),
  • requires in-patient hospitalization or prolongation of existing hospitalization,
  • results in persistent or significant disability/incapacity,
  • congenital anomaly/birth defect, and/or
  • other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.

Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by study drug?”

Time Frame From the first dose of study drug until 4 weeks after last dose; 28 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (all participants who received at least one dose of study drug)
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description:
Participants received weekly subcutaneous placebo for 24 weeks.
Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
Overall Number of Participants Analyzed 19 42
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 19 41
Serious adverse events (SAE) 1 10
AE leading to discontinuation of study drug 0 0
AE leading to discontinuation from study 0 0
Grade 3 AE 3 6
Grade 4 AE 1 2
Grade 5 AE 0 0
Treatment-related adverse events (TRAE) 5 11
Treatment-related serious adverse events 0 1
TRAE leading to discontinuation of study drug 0 0
TRAE leading to discontinuation from study 0 0
TRAE Grade 3 0 1
TRAE Grade 4 0 0
TRAE Grade 5 0 0
Time Frame From the first dose of study drug until 4 weeks after last dose; 28 weeks.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Placebo Romiplostim
Hide Arm/Group Description Participants received weekly subcutaneous placebo for 24 weeks. Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
All-Cause Mortality
Placebo Romiplostim
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Romiplostim
Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   10/42 (23.81%) 
Blood and lymphatic system disorders     
Thrombocytosis  1  0/19 (0.00%)  1/42 (2.38%) 
Gastrointestinal disorders     
Nausea  1  0/19 (0.00%)  1/42 (2.38%) 
Vomiting  1  0/19 (0.00%)  1/42 (2.38%) 
General disorders     
Pyrexia  1  0/19 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Bronchiolitis  1  0/19 (0.00%)  1/42 (2.38%) 
Urinary Tract Infection  1  0/19 (0.00%)  1/42 (2.38%) 
Injury, poisoning and procedural complications     
Animal Bite  1  1/19 (5.26%)  0/42 (0.00%) 
Contusion  1  0/19 (0.00%)  1/42 (2.38%) 
Nervous system disorders     
Headache  1  0/19 (0.00%)  2/42 (4.76%) 
Petit Mal Epilepsy  1  0/19 (0.00%)  1/42 (2.38%) 
Renal and urinary disorders     
Haematuria  1  1/19 (5.26%)  0/42 (0.00%) 
Nephrotic Syndrome  1  0/19 (0.00%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/19 (0.00%)  2/42 (4.76%) 
Skin and subcutaneous tissue disorders     
Petechiae  1  0/19 (0.00%)  1/42 (2.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Romiplostim
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   41/42 (97.62%) 
Blood and lymphatic system disorders     
Anaemia  1  1/19 (5.26%)  2/42 (4.76%) 
Increased Tendency To Bruise  1  1/19 (5.26%)  0/42 (0.00%) 
Iron Deficiency Anaemia  1  2/19 (10.53%)  1/42 (2.38%) 
Lymphadenopathy  1  1/19 (5.26%)  3/42 (7.14%) 
Ear and labyrinth disorders     
Ear Pain  1  2/19 (10.53%)  2/42 (4.76%) 
Eye disorders     
Conjunctival Haemorrhage  1  1/19 (5.26%)  0/42 (0.00%) 
Scleral Discolouration  1  1/19 (5.26%)  0/42 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  3/19 (15.79%)  4/42 (9.52%) 
Abdominal Pain Upper  1  1/19 (5.26%)  5/42 (11.90%) 
Constipation  1  1/19 (5.26%)  5/42 (11.90%) 
Diarrhoea  1  3/19 (15.79%)  10/42 (23.81%) 
Dyspepsia  1  1/19 (5.26%)  0/42 (0.00%) 
Faeces Discoloured  1  1/19 (5.26%)  0/42 (0.00%) 
Gastrointestinal Haemorrhage  1  1/19 (5.26%)  0/42 (0.00%) 
Gingival Bleeding  1  4/19 (21.05%)  8/42 (19.05%) 
Lip Haemorrhage  1  1/19 (5.26%)  2/42 (4.76%) 
Loose Tooth  1  1/19 (5.26%)  0/42 (0.00%) 
Mouth Haemorrhage  1  4/19 (21.05%)  11/42 (26.19%) 
Mouth Ulceration  1  1/19 (5.26%)  0/42 (0.00%) 
Nausea  1  7/19 (36.84%)  8/42 (19.05%) 
Oral Disorder  1  1/19 (5.26%)  1/42 (2.38%) 
Stomatitis  1  1/19 (5.26%)  3/42 (7.14%) 
Tooth Socket Haemorrhage  1  2/19 (10.53%)  1/42 (2.38%) 
Vomiting  1  4/19 (21.05%)  11/42 (26.19%) 
General disorders     
Asthenia  1  1/19 (5.26%)  0/42 (0.00%) 
Chest Pain  1  1/19 (5.26%)  0/42 (0.00%) 
Fatigue  1  5/19 (26.32%)  7/42 (16.67%) 
Injection Site Bruising  1  2/19 (10.53%)  4/42 (9.52%) 
Injection Site Pain  1  1/19 (5.26%)  4/42 (9.52%) 
Localised Oedema  1  1/19 (5.26%)  0/42 (0.00%) 
Nodule  1  1/19 (5.26%)  0/42 (0.00%) 
Non-Cardiac Chest Pain  1  1/19 (5.26%)  0/42 (0.00%) 
Oedema Peripheral  1  1/19 (5.26%)  0/42 (0.00%) 
Pain  1  1/19 (5.26%)  4/42 (9.52%) 
Peripheral Swelling  1  0/19 (0.00%)  4/42 (9.52%) 
Pyrexia  1  2/19 (10.53%)  9/42 (21.43%) 
Vessel Puncture Site Bruise  1  1/19 (5.26%)  0/42 (0.00%) 
Infections and infestations     
Folliculitis  1  1/19 (5.26%)  1/42 (2.38%) 
Gastroenteritis  1  0/19 (0.00%)  3/42 (7.14%) 
Nasopharyngitis  1  3/19 (15.79%)  2/42 (4.76%) 
Oral Herpes  1  1/19 (5.26%)  1/42 (2.38%) 
Pharyngitis Streptococcal  1  0/19 (0.00%)  3/42 (7.14%) 
Pneumonia  1  2/19 (10.53%)  0/42 (0.00%) 
Sinusitis Bacterial  1  1/19 (5.26%)  0/42 (0.00%) 
Tooth Abscess  1  1/19 (5.26%)  0/42 (0.00%) 
Upper Respiratory Tract Infection  1  5/19 (26.32%)  16/42 (38.10%) 
Urinary Tract Infection  1  1/19 (5.26%)  1/42 (2.38%) 
Viral Infection  1  1/19 (5.26%)  1/42 (2.38%) 
Viral Upper Respiratory Tract Infection  1  1/19 (5.26%)  3/42 (7.14%) 
Injury, poisoning and procedural complications     
Animal Bite  1  1/19 (5.26%)  0/42 (0.00%) 
Animal Scratch  1  1/19 (5.26%)  0/42 (0.00%) 
Arthropod Bite  1  1/19 (5.26%)  0/42 (0.00%) 
Burns Second Degree  1  1/19 (5.26%)  0/42 (0.00%) 
Contusion  1  7/19 (36.84%)  21/42 (50.00%) 
Head Injury  1  2/19 (10.53%)  0/42 (0.00%) 
Laceration  1  6/19 (31.58%)  2/42 (4.76%) 
Lip Injury  1  2/19 (10.53%)  0/42 (0.00%) 
Muscle Strain  1  1/19 (5.26%)  0/42 (0.00%) 
Post Procedural Haemorrhage  1  2/19 (10.53%)  1/42 (2.38%) 
Scratch  1  2/19 (10.53%)  6/42 (14.29%) 
Skin Abrasion  1  1/19 (5.26%)  4/42 (9.52%) 
Sunburn  1  1/19 (5.26%)  1/42 (2.38%) 
Thermal Burn  1  1/19 (5.26%)  0/42 (0.00%) 
Tooth Fracture  1  1/19 (5.26%)  0/42 (0.00%) 
Wound  1  1/19 (5.26%)  0/42 (0.00%) 
Wound Haemorrhage  1  1/19 (5.26%)  2/42 (4.76%) 
Investigations     
Platelet Count Decreased  1  3/19 (15.79%)  5/42 (11.90%) 
Weight Increased  1  1/19 (5.26%)  0/42 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  1/19 (5.26%)  3/42 (7.14%) 
Polydipsia  1  1/19 (5.26%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/19 (15.79%)  1/42 (2.38%) 
Back Pain  1  2/19 (10.53%)  4/42 (9.52%) 
Bone Pain  1  2/19 (10.53%)  0/42 (0.00%) 
Joint Range Of Motion Decreased  1  1/19 (5.26%)  0/42 (0.00%) 
Limb Discomfort  1  1/19 (5.26%)  0/42 (0.00%) 
Myalgia  1  1/19 (5.26%)  3/42 (7.14%) 
Pain In Extremity  1  3/19 (15.79%)  5/42 (11.90%) 
Temporomandibular Joint Syndrome  1  1/19 (5.26%)  0/42 (0.00%) 
Nervous system disorders     
Dizziness  1  3/19 (15.79%)  4/42 (9.52%) 
Headache  1  11/19 (57.89%)  17/42 (40.48%) 
Hypoaesthesia  1  1/19 (5.26%)  0/42 (0.00%) 
Presyncope  1  1/19 (5.26%)  0/42 (0.00%) 
Syncope  1  1/19 (5.26%)  0/42 (0.00%) 
Tension Headache  1  1/19 (5.26%)  0/42 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/19 (5.26%)  1/42 (2.38%) 
Depressed Mood  1  1/19 (5.26%)  0/42 (0.00%) 
Insomnia  1  1/19 (5.26%)  2/42 (4.76%) 
Mood Altered  1  1/19 (5.26%)  0/42 (0.00%) 
Stress  1  1/19 (5.26%)  0/42 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/19 (5.26%)  3/42 (7.14%) 
Proteinuria  1  1/19 (5.26%)  2/42 (4.76%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/19 (5.26%)  0/42 (0.00%) 
Menorrhagia  1  1/19 (5.26%)  0/42 (0.00%) 
Metrorrhagia  1  1/19 (5.26%)  2/42 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/19 (5.26%)  8/42 (19.05%) 
Epistaxis  1  10/19 (52.63%)  20/42 (47.62%) 
Nasal Congestion  1  1/19 (5.26%)  5/42 (11.90%) 
Nasal Inflammation  1  1/19 (5.26%)  0/42 (0.00%) 
Oropharyngeal Pain  1  1/19 (5.26%)  11/42 (26.19%) 
Rhinitis Allergic  1  1/19 (5.26%)  2/42 (4.76%) 
Rhinorrhoea  1  2/19 (10.53%)  7/42 (16.67%) 
Skin and subcutaneous tissue disorders     
Acne  1  2/19 (10.53%)  4/42 (9.52%) 
Dry Skin  1  1/19 (5.26%)  2/42 (4.76%) 
Ecchymosis  1  2/19 (10.53%)  4/42 (9.52%) 
Petechiae  1  6/19 (31.58%)  10/42 (23.81%) 
Pruritus  1  1/19 (5.26%)  0/42 (0.00%) 
Purpura  1  0/19 (0.00%)  4/42 (9.52%) 
Rash  1  2/19 (10.53%)  6/42 (14.29%) 
Rash Vesicular  1  1/19 (5.26%)  0/42 (0.00%) 
Scab  1  1/19 (5.26%)  0/42 (0.00%) 
Skin Lesion  1  1/19 (5.26%)  1/42 (2.38%) 
Skin Mass  1  2/19 (10.53%)  0/42 (0.00%) 
Urticaria  1  0/19 (0.00%)  3/42 (7.14%) 
Surgical and medical procedures     
Tooth Extraction  1  1/19 (5.26%)  0/42 (0.00%) 
Vascular disorders     
Haematoma  1  2/19 (10.53%)  4/42 (9.52%) 
Haemorrhage  1  2/19 (10.53%)  2/42 (4.76%) 
Pallor  1  1/19 (5.26%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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: NCT01444417     History of Changes
Other Study ID Numbers: 20080279
2010-018426-39 ( EudraCT Number )
First Submitted: September 29, 2011
First Posted: September 30, 2011
Results First Submitted: November 17, 2016
Results First Posted: January 19, 2017
Last Update Posted: February 9, 2017