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A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

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ClinicalTrials.gov Identifier: NCT00283439
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : September 13, 2010
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Amgen

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Chemotherapy-Induced Thrombocytopenia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Cancer
Oncology
Thrombocytopenia
Intervention Biological: AMG 531
Enrollment 39
Recruitment Details Participants were enrolled from 15 March 2006 through 28 April 2008
Pre-assignment Details  
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Period Title: Overall Study
Started 8 11 11 9
Completed 0 0 0 0
Not Completed 8 11 11 9
Reason Not Completed
Adverse Event             0             0             0             1
Death             0             0             1             0
Disease progression             0             1             0             0
Requirement for alternative therapy             1             2             5             2
Stem cell transplant             6             6             4             3
Treatment discontinued             0             2             1             3
Not specified             1             0             0             0
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg Total
Hide Arm/Group Description Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy Total of all reporting groups
Overall Number of Baseline Participants 8 11 11 9 39
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 8 participants 11 participants 11 participants 9 participants 39 participants
61.3  (6.2) 58.1  (9.5) 54.0  (16.3) 59.9  (10.6) 58.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 11 participants 9 participants 39 participants
Female
3
  37.5%
3
  27.3%
4
  36.4%
5
  55.6%
15
  38.5%
Male
5
  62.5%
8
  72.7%
7
  63.6%
4
  44.4%
24
  61.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 8 participants 11 participants 11 participants 9 participants 39 participants
White or Caucasian 6 10 10 8 34
Black or African American 0 0 1 1 2
Hispanic or Latino 2 1 0 0 3
1.Primary Outcome
Title Change in Platelet Nadir
Hide Description Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
Time Frame 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description:
Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Number of Participants Analyzed 8 11 10 9
Mean (Standard Error)
Unit of Measure: 10^9/L
17.1  (8.3) 11.2  (6.1) 5.1  (6.1) -5.2  (7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 1000 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9654
Comments One-sided test
Method Satterhwaite t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 700 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8690
Comments One-sided test
Method Satterhwaite t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 300 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7133
Comments One-sided test
Method Satterhwaite t-test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
Time Frame 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description:
Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Number of Participants Analyzed 8 11 10 9
Measure Type: Number
Unit of Measure: Percentage of participants
62.5 81.8 80.0 88.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 1000 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 700 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.608
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 300 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.603
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Duration of Grade 3 or 4 Thrombocytopenia
Hide Description Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
Time Frame 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description:
Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Number of Participants Analyzed 8 11 10 9
Mean (Standard Error)
Unit of Measure: Day
3.9  (1.3) 3.6  (0.9) 6.0  (1.5) 8.3  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 1000 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method Satterhwaite t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 700 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method Satterhwaite t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 300 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments [Not Specified]
Method Satterhwaite t-test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects That Received Platelet Transfusions
Hide Description Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
Time Frame 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description:
Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Overall Number of Participants Analyzed 8 11 10 9
Measure Type: Number
Unit of Measure: Percentage of participants
12.5 0.0 30.0 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 1000 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 700 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Romiplostim 100 µg, Romiplostim 300 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.421
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer.
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   1/11 (9.09%)   3/11 (27.27%)   3/9 (33.33%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  0/8 (0.00%)  1/11 (9.09%)  1/11 (9.09%)  2/9 (22.22%) 
Gastrointestinal disorders         
Abdominal pain  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
Gastrointestinal haemorrhage  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
General disorders         
Mucosal inflammation  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Infections and infestations         
Bacteraemia  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Clostridium difficile colitis  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Device related infection  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Staphylococcal infection  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Upper respiratory tract infection  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Urinary tract infection  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Convulsion  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Hypoxia  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Romiplostim 100 µg Romiplostim 300 µg Romiplostim 700 µg Romiplostim 1000 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   9/11 (81.82%)   7/11 (63.64%)   9/9 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/8 (12.50%)  3/11 (27.27%)  0/11 (0.00%)  3/9 (33.33%) 
Neutropenia  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  3/9 (33.33%) 
Thrombocytopenia  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  2/9 (22.22%) 
Cardiac disorders         
Diastolic dysfunction  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Palpitations  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Ear and labyrinth disorders         
Ear pain  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Tinnitus  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Vertigo  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Eye disorders         
Vision blurred  1  0/8 (0.00%)  1/11 (9.09%)  1/11 (9.09%)  0/9 (0.00%) 
Visual disturbance  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Abdominal pain  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Constipation  1  0/8 (0.00%)  2/11 (18.18%)  0/11 (0.00%)  1/9 (11.11%) 
Diarrhoea  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Dysphagia  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Gastric haemorrhage  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Haemorrhoids  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Hyperchlorhydria  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Nausea  1  0/8 (0.00%)  5/11 (45.45%)  1/11 (9.09%)  1/9 (11.11%) 
Oesophagitis  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Rectal fissure  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Stomatitis  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Vomiting  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
General disorders         
Asthenia  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Catheter site pain  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
Catheter site related reaction  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Fatigue  1  1/8 (12.50%)  2/11 (18.18%)  1/11 (9.09%)  4/9 (44.44%) 
Influenza like illness  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Oedema peripheral  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  3/9 (33.33%) 
Pain  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Pyrexia  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  2/9 (22.22%) 
Infections and infestations         
Cellulitis  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Folliculitis  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Oral candidiasis  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  1/9 (11.11%) 
Rhinitis  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod bite  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Back injury  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Contusion  1  1/8 (12.50%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Excoriation  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Investigations         
Blood alkaline phosphatase increased  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Electrocardiogram QT prolonged  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Weight decreased  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  3/9 (33.33%) 
Hypomagnesaemia  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
Hypophosphataemia  1  0/8 (0.00%)  0/11 (0.00%)  2/11 (18.18%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Back pain  1  1/8 (12.50%)  2/11 (18.18%)  0/11 (0.00%)  0/9 (0.00%) 
Bone pain  1  0/8 (0.00%)  2/11 (18.18%)  0/11 (0.00%)  0/9 (0.00%) 
Groin pain  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  1/9 (11.11%) 
Muscle spasms  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Musculoskeletal pain  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Neck pain  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Pain in extremity  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  2/9 (22.22%) 
Pain in jaw  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Dizziness  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
Headache  1  1/8 (12.50%)  1/11 (9.09%)  1/11 (9.09%)  0/9 (0.00%) 
Neuropathy peripheral  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Paraesthesia  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Peripheral sensory neuropathy  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Tremor  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Psychiatric disorders         
Anxiety  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Depression  1  1/8 (12.50%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Insomnia  1  2/8 (25.00%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders         
Chromaturia  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Dysuria  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  2/9 (22.22%) 
Haematuria  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Nocturia  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  1/9 (11.11%) 
Pollakiuria  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Urine flow decreased  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Reproductive system and breast disorders         
Penile oedema  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Dyspnoea exertional  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Epistaxis  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  2/9 (22.22%) 
Nasal congestion  1  0/8 (0.00%)  2/11 (18.18%)  0/11 (0.00%)  0/9 (0.00%) 
Pharyngolaryngeal pain  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Productive cough  1  1/8 (12.50%)  0/11 (0.00%)  0/11 (0.00%)  0/9 (0.00%) 
Rhinorrhoea  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  2/8 (25.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Ecchymosis  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Increased tendency to bruise  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Petechiae  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Rash  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Skin lesion  1  0/8 (0.00%)  0/11 (0.00%)  0/11 (0.00%)  1/9 (11.11%) 
Surgical and medical procedures         
Haematopoietic stem cell mobilisation  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Vascular disorders         
Flushing  1  0/8 (0.00%)  1/11 (9.09%)  0/11 (0.00%)  0/9 (0.00%) 
Hypotension  1  0/8 (0.00%)  0/11 (0.00%)  1/11 (9.09%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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 multi-center 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: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00283439     History of Changes
Other Study ID Numbers: 20050144
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: August 13, 2010
Results First Posted: September 13, 2010
Last Update Posted: June 20, 2011