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Trial record 3 of 183 for:    carfilzomib OR pr-171

A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

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ClinicalTrials.gov Identifier: NCT00884312
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Solid Tumors
Intervention Drug: Carfilzomib
Enrollment 101
Recruitment Details This study was conducted at 23 centers in the United States and Canada from April 2009 to May 2017.
Pre-assignment Details  
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Period Title: Overall Study
Started 9 92
Received Treatment 9 91
Completed [1] 7 67
Not Completed 2 25
Reason Not Completed
Non-fatal Progressive Disease             0             8
Fatal Progressive Disease             0             1
Non-fatal Adverse Event             1             0
Fatal Adverse Event             1             4
Withdrawal by Subject             0             6
Physician Decision             0             1
Other             0             4
Did Not Receive Study Drug             0             1
[1]
Completed final visit
Arm/Group Title Solid Tumors Multiple Myeloma Total
Hide Arm/Group Description Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. Total of all reporting groups
Overall Number of Baseline Participants 9 91 100
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 91 participants 100 participants
61.2  (12.75) 63.2  (9.82) 63.0  (10.05)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 91 participants 100 participants
< 65 years
5
  55.6%
47
  51.6%
52
  52.0%
≥ 65 years
4
  44.4%
44
  48.4%
48
  48.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 91 participants 100 participants
Female
6
  66.7%
38
  41.8%
44
  44.0%
Male
3
  33.3%
53
  58.2%
56
  56.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 91 participants 100 participants
White
9
 100.0%
71
  78.0%
80
  80.0%
Black
0
   0.0%
11
  12.1%
11
  11.0%
Hispanic
0
   0.0%
5
   5.5%
5
   5.0%
Asian/Pacific Islander
0
   0.0%
4
   4.4%
4
   4.0%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 91 participants 100 participants
0 (Fully active)
6
  66.7%
39
  42.9%
45
  45.0%
1 (Restricted but ambulatory)
3
  33.3%
42
  46.2%
45
  45.0%
2 (Ambulatory but unable to work)
0
   0.0%
10
  11.0%
10
  10.0%
[1]
Measure Description: A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
1.Primary Outcome
Title Number of Participants With Peripheral Neuropathy
Hide Description Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.
Time Frame From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description:
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Overall Number of Participants Analyzed 9 91
Measure Type: Number
Unit of Measure: participants
1 15
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0.

Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade).

A serious AE is one that met one or more of the following criteria:

  • Death
  • Life threatening
  • Required inpatient hospitalization or prolongation of an existing hospitalization
  • Resulted in persistent or significant disability/incapacity
  • A congenital anomaly/birth defect in the offspring of an exposed subject
  • Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above.
Time Frame From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description:
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Overall Number of Participants Analyzed 9 91
Measure Type: Number
Unit of Measure: participants
Any adverse event 7 84
Adverse event ≥ grade 3 5 66
Serious adverse events 5 57
Fatal adverse events 1 7
AE leading to discontinuation of carfilzomib 5 20
3.Secondary Outcome
Title Overall Survival
Hide Description Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.
Time Frame From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description:
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Overall Number of Participants Analyzed 9 91
Measure Type: Number
Unit of Measure: participants
1 7
4.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.

Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.

PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.

Time Frame From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data. Only participants with regimens that continued from the initial study without baseline being reset are included.
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description:
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Overall Number of Participants Analyzed 6 58
Median (95% Confidence Interval)
Unit of Measure: months
41.9 [1] 
(NA to NA)
19.6
(10.2 to 30.6)
[1]
In this cohort participants were not followed until confirmed progressive disease. Only one participant was followed until an event; therefore PFS data were not mature and confidence interval could not be calculated.
5.Secondary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.
Time Frame From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data Only participants with regimens that continued from the initial study without baseline being reset are included.
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description:
Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Overall Number of Participants Analyzed 6 58
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
19.6
(10.2 to 30.6)
[1]
Could not be estimated due to the low number of events
Time Frame From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
Adverse Event Reporting Description

The protocol indicated that AEs leading to dose modification, dose discontinuation, CTCAE grade 3+, serious AEs and all-grade peripheral neuropathy AEs were collected in the study.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

 
Arm/Group Title Solid Tumors Multiple Myeloma
Hide Arm/Group Description Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant’s previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
All-Cause Mortality
Solid Tumors Multiple Myeloma
Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   7/91 (7.69%) 
Show Serious Adverse Events Hide Serious Adverse Events
Solid Tumors Multiple Myeloma
Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   57/91 (62.64%) 
Blood and lymphatic system disorders     
Anaemia  1  0/9 (0.00%)  1/91 (1.10%) 
Febrile neutropenia  1  0/9 (0.00%)  5/91 (5.49%) 
Haemolytic uraemic syndrome  1  0/9 (0.00%)  1/91 (1.10%) 
Cardiac disorders     
Acute myocardial infarction  1  0/9 (0.00%)  1/91 (1.10%) 
Atrial fibrillation  1  0/9 (0.00%)  2/91 (2.20%) 
Cardiac failure congestive  1  0/9 (0.00%)  3/91 (3.30%) 
Cardiac tamponade  1  1/9 (11.11%)  0/91 (0.00%) 
Cardiomyopathy  1  1/9 (11.11%)  0/91 (0.00%) 
Coronary artery occlusion  1  0/9 (0.00%)  1/91 (1.10%) 
Myocardial infarction  1  0/9 (0.00%)  3/91 (3.30%) 
Tachycardia  1  0/9 (0.00%)  1/91 (1.10%) 
Ear and labyrinth disorders     
Vertigo  1  0/9 (0.00%)  1/91 (1.10%) 
Gastrointestinal disorders     
Colitis  1  0/9 (0.00%)  1/91 (1.10%) 
Diarrhoea  1  0/9 (0.00%)  3/91 (3.30%) 
Gastrointestinal haemorrhage  1  0/9 (0.00%)  1/91 (1.10%) 
Nausea  1  0/9 (0.00%)  2/91 (2.20%) 
General disorders     
Asthenia  1  0/9 (0.00%)  1/91 (1.10%) 
Chest pain  1  0/9 (0.00%)  1/91 (1.10%) 
Disease progression  1  0/9 (0.00%)  2/91 (2.20%) 
Infusion related reaction  1  0/9 (0.00%)  1/91 (1.10%) 
Non-cardiac chest pain  1  0/9 (0.00%)  1/91 (1.10%) 
Pain  1  0/9 (0.00%)  2/91 (2.20%) 
Pyrexia  1  0/9 (0.00%)  2/91 (2.20%) 
Infections and infestations     
Bronchiolitis  1  0/9 (0.00%)  1/91 (1.10%) 
Bronchitis  1  0/9 (0.00%)  3/91 (3.30%) 
Catheter sepsis  1  0/9 (0.00%)  1/91 (1.10%) 
Cellulitis  1  0/9 (0.00%)  3/91 (3.30%) 
Chronic sinusitis  1  0/9 (0.00%)  1/91 (1.10%) 
Clostridial infection  1  0/9 (0.00%)  1/91 (1.10%) 
Endocarditis bacterial  1  0/9 (0.00%)  1/91 (1.10%) 
Gastroenteritis viral  1  0/9 (0.00%)  1/91 (1.10%) 
Haemophilus sepsis  1  0/9 (0.00%)  1/91 (1.10%) 
Herpes zoster ophthalmic  1  1/9 (11.11%)  0/91 (0.00%) 
Infection  1  1/9 (11.11%)  0/91 (0.00%) 
Influenza  1  0/9 (0.00%)  6/91 (6.59%) 
Intraspinal abscess  1  0/9 (0.00%)  1/91 (1.10%) 
Klebsiella bacteraemia  1  0/9 (0.00%)  1/91 (1.10%) 
Lobar pneumonia  1  0/9 (0.00%)  1/91 (1.10%) 
Lung infection  1  0/9 (0.00%)  1/91 (1.10%) 
Neutropenic sepsis  1  0/9 (0.00%)  1/91 (1.10%) 
Otitis media  1  0/9 (0.00%)  1/91 (1.10%) 
Pneumonia  1  1/9 (11.11%)  10/91 (10.99%) 
Pneumonia pneumococcal  1  0/9 (0.00%)  1/91 (1.10%) 
Pneumonia respiratory syncytial viral  1  0/9 (0.00%)  2/91 (2.20%) 
Pneumonia viral  1  0/9 (0.00%)  1/91 (1.10%) 
Respiratory syncytial virus infection  1  0/9 (0.00%)  1/91 (1.10%) 
Sepsis  1  1/9 (11.11%)  3/91 (3.30%) 
Sinusitis  1  0/9 (0.00%)  2/91 (2.20%) 
Staphylococcal bacteraemia  1  0/9 (0.00%)  1/91 (1.10%) 
Staphylococcal sepsis  1  0/9 (0.00%)  1/91 (1.10%) 
Streptococcal infection  1  0/9 (0.00%)  1/91 (1.10%) 
Tooth infection  1  0/9 (0.00%)  1/91 (1.10%) 
Upper respiratory tract infection  1  0/9 (0.00%)  1/91 (1.10%) 
Urinary tract infection pseudomonal  1  0/9 (0.00%)  1/91 (1.10%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  0/9 (0.00%)  1/91 (1.10%) 
Fall  1  0/9 (0.00%)  1/91 (1.10%) 
Femoral neck fracture  1  0/9 (0.00%)  1/91 (1.10%) 
Femur fracture  1  0/9 (0.00%)  2/91 (2.20%) 
Fracture  1  0/9 (0.00%)  1/91 (1.10%) 
Hip fracture  1  0/9 (0.00%)  1/91 (1.10%) 
Lumbar vertebral fracture  1  0/9 (0.00%)  1/91 (1.10%) 
Investigations     
Transaminases increased  1  0/9 (0.00%)  1/91 (1.10%) 
Metabolism and nutrition disorders     
Dehydration  1  0/9 (0.00%)  2/91 (2.20%) 
Hypercalcaemia  1  0/9 (0.00%)  1/91 (1.10%) 
Hypoglycaemia  1  0/9 (0.00%)  1/91 (1.10%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/9 (11.11%)  1/91 (1.10%) 
Back pain  1  0/9 (0.00%)  3/91 (3.30%) 
Osteolysis  1  0/9 (0.00%)  1/91 (1.10%) 
Pain in extremity  1  0/9 (0.00%)  1/91 (1.10%) 
Pathological fracture  1  0/9 (0.00%)  2/91 (2.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/9 (0.00%)  1/91 (1.10%) 
Renal cell carcinoma stage unspecified  1  0/9 (0.00%)  1/91 (1.10%) 
Nervous system disorders     
Cerebrovascular accident  1  0/9 (0.00%)  2/91 (2.20%) 
Dizziness  1  0/9 (0.00%)  1/91 (1.10%) 
Spinal cord compression  1  0/9 (0.00%)  1/91 (1.10%) 
Syncope  1  0/9 (0.00%)  1/91 (1.10%) 
Psychiatric disorders     
Delirium  1  0/9 (0.00%)  1/91 (1.10%) 
Mental status changes  1  0/9 (0.00%)  1/91 (1.10%) 
Renal and urinary disorders     
Haematuria  1  0/9 (0.00%)  1/91 (1.10%) 
Renal failure acute  1  1/9 (11.11%)  4/91 (4.40%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/9 (0.00%)  1/91 (1.10%) 
Chronic obstructive pulmonary disease  1  0/9 (0.00%)  1/91 (1.10%) 
Cough  1  0/9 (0.00%)  1/91 (1.10%) 
Dyspnoea  1  0/9 (0.00%)  4/91 (4.40%) 
Dyspnoea exertional  1  0/9 (0.00%)  1/91 (1.10%) 
Pleural effusion  1  0/9 (0.00%)  1/91 (1.10%) 
Pneumonitis  1  0/9 (0.00%)  1/91 (1.10%) 
Pulmonary embolism  1  0/9 (0.00%)  1/91 (1.10%) 
Pulmonary haemorrhage  1  1/9 (11.11%)  0/91 (0.00%) 
Pulmonary hypertension  1  0/9 (0.00%)  2/91 (2.20%) 
Respiratory failure  1  0/9 (0.00%)  2/91 (2.20%) 
1
Term from vocabulary, MedDRA 8.1
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%
Solid Tumors Multiple Myeloma
Affected / at Risk (%) Affected / at Risk (%)
Total   6/9 (66.67%)   69/91 (75.82%) 
Blood and lymphatic system disorders     
Anaemia  1  0/9 (0.00%)  18/91 (19.78%) 
Neutropenia  1  0/9 (0.00%)  19/91 (20.88%) 
Thrombocytopenia  1  0/9 (0.00%)  16/91 (17.58%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/9 (11.11%)  0/91 (0.00%) 
Abdominal distension  1  1/9 (11.11%)  0/91 (0.00%) 
Abdominal pain  1  1/9 (11.11%)  0/91 (0.00%) 
Ascites  1  1/9 (11.11%)  0/91 (0.00%) 
Diarrhoea  1  0/9 (0.00%)  12/91 (13.19%) 
Nausea  1  2/9 (22.22%)  11/91 (12.09%) 
Vomiting  1  3/9 (33.33%)  5/91 (5.49%) 
General disorders     
Asthenia  1  1/9 (11.11%)  1/91 (1.10%) 
Chills  1  1/9 (11.11%)  1/91 (1.10%) 
Fatigue  1  3/9 (33.33%)  16/91 (17.58%) 
Infusion site pain  1  1/9 (11.11%)  1/91 (1.10%) 
Pyrexia  1  2/9 (22.22%)  4/91 (4.40%) 
Sensation of pressure  1  1/9 (11.11%)  0/91 (0.00%) 
Immune system disorders     
Seasonal allergy  1  1/9 (11.11%)  0/91 (0.00%) 
Infections and infestations     
Bronchitis  1  1/9 (11.11%)  1/91 (1.10%) 
Herpes simplex  1  1/9 (11.11%)  0/91 (0.00%) 
Nasopharyngitis  1  2/9 (22.22%)  1/91 (1.10%) 
Pneumonia  1  0/9 (0.00%)  6/91 (6.59%) 
Sinusitis  1  1/9 (11.11%)  3/91 (3.30%) 
Upper respiratory tract infection  1  1/9 (11.11%)  21/91 (23.08%) 
Urinary tract infection  1  1/9 (11.11%)  1/91 (1.10%) 
Investigations     
Blood creatinine increased  1  0/9 (0.00%)  5/91 (5.49%) 
Metabolism and nutrition disorders     
Dehydration  1  1/9 (11.11%)  1/91 (1.10%) 
Hyperglycaemia  1  0/9 (0.00%)  5/91 (5.49%) 
Hypophosphataemia  1  0/9 (0.00%)  6/91 (6.59%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/9 (0.00%)  5/91 (5.49%) 
Pain in extremity  1  1/9 (11.11%)  7/91 (7.69%) 
Nervous system disorders     
Dysarthria  1  1/9 (11.11%)  0/91 (0.00%) 
Facial palsy  1  1/9 (11.11%)  0/91 (0.00%) 
Headache  1  1/9 (11.11%)  0/91 (0.00%) 
Hypoaesthesia  1  1/9 (11.11%)  1/91 (1.10%) 
Neuropathy peripheral  1  0/9 (0.00%)  10/91 (10.99%) 
Transient ischaemic attack  1  1/9 (11.11%)  0/91 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/9 (11.11%)  1/91 (1.10%) 
Insomnia  1  1/9 (11.11%)  3/91 (3.30%) 
Renal and urinary disorders     
Dysuria  1  1/9 (11.11%)  0/91 (0.00%) 
Urinary incontinence  1  1/9 (11.11%)  1/91 (1.10%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/9 (22.22%)  14/91 (15.38%) 
Pharyngolaryngeal pain  1  1/9 (11.11%)  1/91 (1.10%) 
Rhinorrhoea  1  1/9 (11.11%)  1/91 (1.10%) 
Sinus congestion  1  1/9 (11.11%)  1/91 (1.10%) 
Wheezing  1  1/9 (11.11%)  2/91 (2.20%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  1/9 (11.11%)  2/91 (2.20%) 
1
Term from vocabulary, MedDRA 8.1
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: NCT00884312     History of Changes
Other Study ID Numbers: PX-171-010
20130394 ( Other Identifier: Amgen Study ID )
First Submitted: April 16, 2009
First Posted: April 20, 2009
Results First Submitted: April 9, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018