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Trial record 36 of 36 for:    DANAZOL

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279173
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : August 26, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Immune Thrombocytopenia
Intervention Drug: Romiplostim
Enrollment 204
Recruitment Details

Children with immune thrombocytopenic purpura (ITP) and platelet counts ≤ 30×10⁹/L or uncontrolled bleeding were enrolled from December 2014 to August 2016 at 66 centers in 16 countries worldwide, including Eastern Europe (44%), Western Europe (25%), and US/Canada (21%).

The study is currently ongoing; results are reported as of 30 August 2018.

Pre-assignment Details

All participants were assigned to receive weekly romiplostim.

A subset of participants enrolled under the protocol supplement in the European Union (EU), Switzerland, and Turkey were enrolled into the following 2 cohorts:

  • bone marrow biopsy and aspirate at baseline and year 1
  • bone marrow biopsy and aspirate at baseline and year 2
Arm/Group Title Romiplostim
Hide Arm/Group Description Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Period Title: Overall Study
Started 204
Received Treatment 203
Enrolled Under Protocol Supplement 79
Completed [1] 37
Not Completed 167
Reason Not Completed
Ongoing             78
Protocol-specified Criteria             64
Withdrawal by Subject             17
Decision by Sponsor             4
Lost to Follow-up             3
Enrolled But Did Not Receive Treatment             1
[1]
As of 30 August 2018
Arm/Group Title Romiplostim
Hide Arm/Group Description Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Baseline Participants 204
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 204 participants
10.0
(1 to 17)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants
≥ 1 to < 6 years
50
  24.5%
≥ 6 to < 12 years
81
  39.7%
≥ 12 to < 18 years
73
  35.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants
Female
103
  50.5%
Male
101
  49.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants
American Indian or Alaska Native
4
   2.0%
Asian
12
   5.9%
Black or African American
11
   5.4%
Multiple
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Other
12
   5.9%
White
164
  80.4%
Years Since ITP Diagnosis   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 203 participants
1.75
(0.5 to 13.8)
[1]
Measure Analysis Population Description: Participants with available data
Age at ITP Diagnosis   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 203 participants
5.97
(0.6 to 17.3)
[1]
Measure Analysis Population Description: Participants with available data
Splenectomy Done  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants
Yes
10
   4.9%
No
194
  95.1%
Platelet Count   [1] 
Median (Full Range)
Unit of measure:  10⁹/L
Number Analyzed 203 participants
14.00
(1.5 to 265.0)
[1]
Measure Analysis Population Description: Participants with available data
Number of Prior ITP Treatments   [1] 
Median (Full Range)
Unit of measure:  Prior ITP treatments
Number Analyzed 203 participants
2.0
(1 to 7)
[1]
Measure Analysis Population Description: Participants with available data
1.Primary Outcome
Title Percentage of Time With a Platelet Response During the First 6 Months of Treatment
Hide Description

Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP in the past 4 weeks.

Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.

Time Frame Week 2 to Month 6, platelet response was assessed every week.
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
50.00
(16.67 to 83.33)
2.Primary Outcome
Title Percentage of Participants Who Developed Collagen After Exposure to Romiplostim
Hide Description

The percentage of participants who developed collagen as evidenced by trichrome staining, defined as a Grade 4 on the modified Bauermeister grading scale:

Grade 0: No reticulin fibers demonstrable

Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers

Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)

Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)

Time Frame Year 1 (Cohort 1) and year 2 (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
Overall Number of Participants Analyzed 27 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.8)
0.0
(0.0 to 10.0)
3.Primary Outcome
Title Percentage of Participants With Increased Modified Bauermeister Grade
Hide Description

The percentage of participants with an increased modified Bauermeister grade defined as an increase by ≥ 2 severity grades or an increase to grade 4 (i.e., grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister grading scale:

Grade 0: No reticulin fibers demonstrable

Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers

Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)

Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)

Participants without an evaluable baseline result were assumed to have a baseline modified Bauermeister score of 0.

Time Frame Baseline, year 1 (Cohort 1) and year 2 (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
Overall Number of Participants Analyzed 27 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.7
(0.1 to 19.0)
0.0
(0.0 to 10.0)
4.Primary Outcome
Title Percentage of Participants Who Developed Bone Marrow Abnormalities
Hide Description The percentage of participants with bone marrow abnormalities (eg, myelodysplastic syndrome, monosomy 7) based on analysis of bone marrow biopsy and aspirate samples using cytogenetics and fluorescence in situ hybridization.
Time Frame Year 1 (Cohort 1) and year 2 (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Bone marrow analysis set participants with an on-study bone marrow abnormality assessment
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
Overall Number of Participants Analyzed 27 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 12.8)
0.0
(0.0 to 11.6)
5.Secondary Outcome
Title Percentage of Time With a Platelet Response During the Overall Treatment Period
Hide Description

Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use in the past 4 weeks.

Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.

Time Frame From week 2 to the end of the treatment period, 36 months, up to the data cut-off date of 20 March 2017.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
70.59
(21.43 to 88.14)
6.Secondary Outcome
Title Percentage of Time With an Increase in Platelet Count ≥ 20 x10⁹/L Above Baseline
Hide Description

The percentage of time with an increase in platelet count ≥ 20 x 10⁹/L above baseline from week 2 until the end of the treatment period without rescue medication use within the past 4 weeks.

For each participant, the percentage of time with an increase in platelet count ≥ 20 x10⁹/L above baseline was calculated as the number of months the median platelet count was ≥ 20 x10⁹/L above baseline divided by the total number of months assessed.

Time Frame Baseline and from week 2 to month 36, up to the data cut-off date of 20 March 2017.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 203
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
74.36
(39.13 to 90.20)
7.Secondary Outcome
Title Number of Participants Reporting Use of Rescue Medications for ITP During the Treatment Period
Hide Description

Rescue medication is defined as any medication or transfusion, other than romiplostim and excluded medications, that is administered after enrollment to the participant with the intent of raising platelet counts or to prevent bleeding and includes concomitant medications for ITP in which the dose and/or schedule was increased. Permitted rescue medications included the following:

  • corticosteroids
  • platelet transfusions
  • Intravenous immunoglobulin (IVIG)
  • azathioprine
  • anti-D immunoglobulin
  • danazol
Time Frame From first dose of romiplostim to the end of the treatment period, 36 months, up to the data cut-off date of 20 March 2017.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
52
  25.6%
8.Secondary Outcome
Title Number of Participants Who Developed Anti-Romiplostim or Anti- Thrombopoietin Neutralizing Antibodies
Hide Description

Blood samples were first tested for the presence of binding antibodies to romiplostim or the peptide portion of romiplostim, and to endogenous thrombopoietin (eTPO). Samples testing positive for binding antibodies were then tested for neutralizing antibodies by assessing their ability to neutralize romiplostim and/or eTPO in a cell-based bioassay.

Participants who developed neutralizing antibodies are those who had a postbaseline positive result with a negative or no result at baseline. Transient is defined as a negative result at the participant's last time point tested within the study period.

Time Frame Week 12, week 52 and every 24 weeks thereafter up to month 36, up to the data cut-off date of 20 March 2017.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of romiplostim and with a post-baseline antibody result.
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 201
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-romiplostim neutralizing antibodies
6
   3.0%
Transient anti-romiplostim neutralizing antibodies
2
   1.0%
Anti-thrombopoietin neutralizing antibodies
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with study treatment.

A serious adverse event was defined as an AE that met at least 1 of the following criteria:

  • fatal
  • life threatening
  • required in-patient hospitalization or prolongation of existing hospitalization
  • resulted in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event

Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = mild AE; Grade 2 = moderate AE; Grade 3 = severe AE; Grade 4 = life-threatening or disabling; Grade 5 = death related to AE.

Time Frame From first dose of study drug to the end of treatment (up to 36 months), up to the data cut-off date of 30 August 2018.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of romiplostim
Arm/Group Title Romiplostim
Hide Arm/Group Description:
Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
Overall Number of Participants Analyzed 203
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event (AE)
190
  93.6%
Serious adverse events (SAE)
59
  29.1%
AEs leading to discontinuation of romiplostim
15
   7.4%
Adverse event Grade ≥ 3
64
  31.5%
Adverse event Grade ≥ 4
18
   8.9%
Adverse event Grade ≥ 5
0
   0.0%
Treatment-related adverse events (TRAE)
56
  27.6%
Treatment-related serious adverse events
8
   3.9%
TRAEs leading to discontinuation of romiplostim
8
   3.9%
Treatment-related adverse events Grade ≥ 3
8
   3.9%
Treatment-related adverse events Grade ≥ 4
0
   0.0%
Treatment-related adverse events Grade ≥ 5
0
   0.0%
10.Secondary Outcome
Title Percentage of Participants Who Developed Increased Reticulin
Hide Description

The percentage of participants with increased reticulin as evidenced by silver staining and defined as any increase from baseline in the modified Bauermeister grade:

Grade 0: No reticulin fibers demonstrable

Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers

Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)

Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)

Participants without an evaluable baseline result were assumed to have a baseline modified Bauermeister score of 0.

Time Frame Baseline, year 1 (Cohort 1) and year 2 (Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 1.
Participants enrolled under the protocol supplement in the EU, Switzerland, or Turkey received weekly romiplostim for 3 years and had a bone marrow biopsy at baseline and year 2.
Overall Number of Participants Analyzed 27 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.5
(6.3 to 38.1)
48.6
(31.4 to 66.0)
Time Frame From first dose of study drug to the end of treatment (up to 36 months), up to the data cut-off date of 30 August 2018.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Romiplostim
Hide Arm/Group Description Participants received romiplostim administered weekly by subcutaneous injection for up to 3 years. The starting dose was 1 µg/kg titrated in 1 µg/kg increments up to a maximum of 10 µg/kg to reach a target platelet count ≥ 50 x 10⁹/L.
All-Cause Mortality
Romiplostim
Affected / at Risk (%)
Total   0/203 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Romiplostim
Affected / at Risk (%)
Total   59/203 (29.06%) 
Blood and lymphatic system disorders   
Anaemia  1  2/203 (0.99%) 
Evans syndrome  1  1/203 (0.49%) 
Haemorrhagic disorder  1  1/203 (0.49%) 
Immune thrombocytopenic purpura  1  3/203 (1.48%) 
Lymphadenitis  1  1/203 (0.49%) 
Thrombocytopenia  1  4/203 (1.97%) 
Thrombocytopenic purpura  1  1/203 (0.49%) 
Cardiac disorders   
Supraventricular tachycardia  1  1/203 (0.49%) 
Gastrointestinal disorders   
Abdominal pain  1  2/203 (0.99%) 
Gingival bleeding  1  1/203 (0.49%) 
Haematemesis  1  1/203 (0.49%) 
Mouth haemorrhage  1  1/203 (0.49%) 
Tooth impacted  1  1/203 (0.49%) 
Infections and infestations   
Appendicitis  1  1/203 (0.49%) 
Cytomegalovirus infection  1  1/203 (0.49%) 
Gastroenteritis rotavirus  1  1/203 (0.49%) 
Influenza  1  2/203 (0.99%) 
Otitis externa  1  1/203 (0.49%) 
Otitis media acute  1  1/203 (0.49%) 
Peritonsillar abscess  1  1/203 (0.49%) 
Pilonidal cyst  1  1/203 (0.49%) 
Pneumonia  1  1/203 (0.49%) 
Staphylococcal abscess  1  1/203 (0.49%) 
Injury, poisoning and procedural complications   
Contusion  1  1/203 (0.49%) 
Head injury  1  1/203 (0.49%) 
Post procedural haemorrhage  1  1/203 (0.49%) 
Road traffic accident  1  1/203 (0.49%) 
Investigations   
Arthroscopy  1  1/203 (0.49%) 
Blood urine present  1  1/203 (0.49%) 
Neutralising antibodies positive  1  4/203 (1.97%) 
Platelet count decreased  1  9/203 (4.43%) 
Musculoskeletal and connective tissue disorders   
Haemarthrosis  1  1/203 (0.49%) 
Mixed connective tissue disease  1  1/203 (0.49%) 
Systemic lupus erythematosus  1  1/203 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
B-cell lymphoma  1  1/203 (0.49%) 
Nervous system disorders   
Headache  1  2/203 (0.99%) 
Presyncope  1  2/203 (0.99%) 
Psychiatric disorders   
Suicidal ideation  1  1/203 (0.49%) 
Renal and urinary disorders   
Haematuria  1  1/203 (0.49%) 
Lupus nephritis  1  1/203 (0.49%) 
Reproductive system and breast disorders   
Gynaecomastia  1  1/203 (0.49%) 
Menorrhagia  1  1/203 (0.49%) 
Metrorrhagia  1  1/203 (0.49%) 
Polymenorrhoea  1  1/203 (0.49%) 
Varicocele  1  1/203 (0.49%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  12/203 (5.91%) 
Interstitial lung disease  1  1/203 (0.49%) 
Status asthmaticus  1  1/203 (0.49%) 
Skin and subcutaneous tissue disorders   
Ecchymosis  1  1/203 (0.49%) 
Haemorrhage subcutaneous  1  1/203 (0.49%) 
Petechiae  1  2/203 (0.99%) 
Purpura  1  1/203 (0.49%) 
Vascular disorders   
Haemorrhage  1  1/203 (0.49%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Romiplostim
Affected / at Risk (%)
Total   181/203 (89.16%) 
Blood and lymphatic system disorders   
Anaemia  1  12/203 (5.91%) 
Ear and labyrinth disorders   
Ear pain  1  12/203 (5.91%) 
Gastrointestinal disorders   
Abdominal pain  1  28/203 (13.79%) 
Abdominal pain upper  1  37/203 (18.23%) 
Diarrhoea  1  38/203 (18.72%) 
Gingival bleeding  1  21/203 (10.34%) 
Mouth haemorrhage  1  16/203 (7.88%) 
Nausea  1  36/203 (17.73%) 
Vomiting  1  47/203 (23.15%) 
General disorders   
Fatigue  1  19/203 (9.36%) 
Pyrexia  1  62/203 (30.54%) 
Immune system disorders   
Hypersensitivity  1  11/203 (5.42%) 
Infections and infestations   
Conjunctivitis  1  12/203 (5.91%) 
Ear infection  1  14/203 (6.90%) 
Gastroenteritis  1  18/203 (8.87%) 
Influenza  1  15/203 (7.39%) 
Nasopharyngitis  1  72/203 (35.47%) 
Pharyngitis  1  31/203 (15.27%) 
Rhinitis  1  40/203 (19.70%) 
Tonsillitis  1  12/203 (5.91%) 
Upper respiratory tract infection  1  37/203 (18.23%) 
Viral infection  1  20/203 (9.85%) 
Injury, poisoning and procedural complications   
Contusion  1  40/203 (19.70%) 
Fall  1  13/203 (6.40%) 
Skin laceration  1  12/203 (5.91%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  21/203 (10.34%) 
Pain in extremity  1  22/203 (10.84%) 
Nervous system disorders   
Dizziness  1  14/203 (6.90%) 
Headache  1  75/203 (36.95%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  51/203 (25.12%) 
Epistaxis  1  71/203 (34.98%) 
Nasal congestion  1  18/203 (8.87%) 
Oropharyngeal pain  1  36/203 (17.73%) 
Rhinorrhoea  1  27/203 (13.30%) 
Skin and subcutaneous tissue disorders   
Ecchymosis  1  19/203 (9.36%) 
Petechiae  1  48/203 (23.65%) 
Rash  1  26/203 (12.81%) 
Vascular disorders   
Haematoma  1  40/203 (19.70%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02279173     History of Changes
Other Study ID Numbers: 20101221
2011-005019-96 ( EudraCT Number )
First Submitted: October 1, 2014
First Posted: October 30, 2014
Results First Submitted: August 8, 2019
Results First Posted: August 26, 2019
Last Update Posted: September 17, 2019