Trial Outcomes & Findings for Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone (NCT NCT00396279)
NCT ID: NCT00396279
Last Updated: 2022-11-08
Results Overview
A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent \< 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From enrollment until 25 weeks
Results posted on
2022-11-08
Participant Flow
First patient enrolled 10 July 2006; Last patient enrolled 25 January 2008. Results data are reported as of the data cut-off date of 07 April 2008.
Participant milestones
| Measure |
Denosumab
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Denosumab
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Overall Study
Ongoing in study
|
26
|
|
Overall Study
Disease progression
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
Baseline characteristics by cohort
| Measure |
Denosumab
n=37 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Giant Cell Tumor Disease Type
Primary unresectable
|
13 participants
n=5 Participants
|
|
Giant Cell Tumor Disease Type
Recurrent unresectable
|
18 participants
n=5 Participants
|
|
Giant Cell Tumor Disease Type
Recurrent resectable
|
6 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
13 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Restricted but ambulatory
|
21 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 - Ambulatory but unable to work
|
1 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 - Limited selfcare, confined to bed >50% daytime
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 - Completely disabled
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
2 participants
n=5 Participants
|
|
Percent of giant cells in tumor on pre-treatment biopsy
|
28.7 percentage of giant cells in tumor
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Location of target lesion
Lower extremities
|
8 participants
n=5 Participants
|
|
Location of target lesion
Upper extremities
|
5 participants
n=5 Participants
|
|
Location of target lesion
Pelvis
|
9 participants
n=5 Participants
|
|
Location of target lesion
Spine
|
3 participants
n=5 Participants
|
|
Location of target lesion
Pulmonary disease
|
9 participants
n=5 Participants
|
|
Location of target lesion
Dorsal vertebrae
|
1 participants
n=5 Participants
|
|
Location of target lesion
Pelvic region
|
1 participants
n=5 Participants
|
|
Location of target lesion
Missing
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment until 25 weeksPopulation: The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose.
A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent \< 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.
Outcome measures
| Measure |
Denosumab
n=35 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Percentage of Participants With Giant Cell Tumor Response
|
85.7 percentage of participants
Interval 69.7 to 95.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81Population: Efficacy Analysis Set with available data at each time point (n).
Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.
Outcome measures
| Measure |
Denosumab
n=35 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 5 (n=30)
|
-70.9 percent change
Interval -79.6 to -15.0
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 9 (n=29)
|
-77.0 percent change
Interval -85.7 to -42.9
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 13 (n=27)
|
-60.0 percent change
Interval -84.2 to -36.0
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 17 (n=26)
|
-59.5 percent change
Interval -79.3 to -37.1
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 21 (n=24)
|
-64.5 percent change
Interval -80.1 to -19.1
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 25 (n=20)
|
-56.4 percent change
Interval -76.2 to 3.6
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 29 (n=21)
|
-52.8 percent change
Interval -78.4 to -22.8
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 33 (n=15)
|
-35.0 percent change
Interval -83.8 to 22.0
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 37 (n=13)
|
-71.1 percent change
Interval -83.4 to -41.4
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 41 (n=11)
|
-57.3 percent change
Interval -78.1 to -22.4
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 45 (n=8)
|
-59.1 percent change
Interval -81.8 to -47.5
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 49 (n=7)
|
-59.0 percent change
Interval -74.0 to -0.9
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 53 (N=8)
|
-49.0 percent change
Interval -81.5 to -29.3
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 57 (n=6)
|
-65.1 percent change
Interval -78.4 to -21.9
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 61 (n=3)
|
-59.2 percent change
Interval -92.5 to 23.1
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 65 (n=3)
|
-69.2 percent change
Interval -79.6 to 33.2
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 69 (n=4)
|
-64.2 percent change
Interval -88.8 to -13.4
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 73 (n=1)
|
-47.5 percent change
Interval -47.5 to -47.5
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 77 (n=2)
|
-76.8 percent change
Interval -86.8 to -66.7
|
|
Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
Week 81 (n=2)
|
-13.3 percent change
Interval -53.8 to 27.1
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81Population: Efficacy Analysis Set with available data at each time point (n).
Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.
Outcome measures
| Measure |
Denosumab
n=35 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 49 (n=7)
|
-82.0 percent change
Interval -90.0 to -76.7
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 5 (n=33)
|
-78.9 percent change
Interval -85.2 to -71.2
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 9 (n=33)
|
-79.8 percent change
Interval -87.9 to -66.1
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 13 (n=31)
|
-80.4 percent change
Interval -85.7 to -71.3
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 17 (n=28)
|
-82.6 percent change
Interval -85.2 to -70.4
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 21 (n=26)
|
-82.0 percent change
Interval -87.0 to -66.4
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 25 (n=24)
|
-79.5 percent change
Interval -86.5 to -69.2
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 29 (n=21)
|
-82.8 percent change
Interval -85.2 to -60.3
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 33 (n=16)
|
-74.8 percent change
Interval -83.2 to -59.0
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 37 (n=14)
|
-82.4 percent change
Interval -87.0 to -69.6
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 41 (n=10)
|
-86.1 percent change
Interval -89.6 to -58.5
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 45 (n=8)
|
-79.6 percent change
Interval -86.4 to -70.0
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 53 (N=8)
|
-87.3 percent change
Interval -89.8 to -84.2
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 57 (n=6)
|
-86.2 percent change
Interval -87.7 to -85.2
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 61 (n=4)
|
-84.9 percent change
Interval -88.3 to -83.0
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 65 (n=3)
|
-83.5 percent change
Interval -87.0 to -77.5
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 69 (n=4)
|
-84.2 percent change
Interval -86.9 to -80.0
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 73 (n=2)
|
-81.9 percent change
Interval -85.2 to -78.5
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 77 (n=2)
|
-84.2 percent change
Interval -87.5 to -80.9
|
|
Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
Week 81 (n=2)
|
-84.9 percent change
Interval -89.6 to -80.3
|
SECONDARY outcome
Timeframe: Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.Population: The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.
Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Denosumab
n=37 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Serum Denosumab Trough Concentrations
Day 1 (n=32)
|
NA ng/mL
Standard Deviation NA
Below the lower limit of quantification
|
|
Serum Denosumab Trough Concentrations
Day 8 (n=32)
|
19000 ng/mL
Standard Deviation 24100
|
|
Serum Denosumab Trough Concentrations
Day 15 (n=28)
|
31600 ng/mL
Standard Deviation 27300
|
|
Serum Denosumab Trough Concentrations
Day 29 (n=33)
|
36400 ng/mL
Standard Deviation 20600
|
|
Serum Denosumab Trough Concentrations
Week 9 (n=32)
|
27500 ng/mL
Standard Deviation 17300
|
|
Serum Denosumab Trough Concentrations
Week 13 (n=25)
|
23300 ng/mL
Standard Deviation 12400
|
|
Serum Denosumab Trough Concentrations
Week 25 (n=23)
|
19900 ng/mL
Standard Deviation 9700
|
|
Serum Denosumab Trough Concentrations
Week 49 (n=9)
|
21400 ng/mL
Standard Deviation 8900
|
SECONDARY outcome
Timeframe: From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 monthsPopulation: All participants who received at least 1 dose of denosumab.
An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.
Outcome measures
| Measure |
Denosumab
n=37 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE
|
33 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious AE
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
Fatal AE
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to study discontinuation
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to study drug discontinuation
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
CTCAE Grade 3, 4, or 5
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
Any AE related to study drug
|
10 participants
|
SECONDARY outcome
Timeframe: From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.Population: Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.
Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.
Outcome measures
| Measure |
Denosumab
n=31 Participants
Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
|
|---|---|
|
Number of Participants With Anti-Denosumab Antibodies
|
0 participants
|
Adverse Events
Denosumab 120 mg Q4W
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab 120 mg Q4W
n=37 participants at risk
Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.7%
1/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
Other adverse events
| Measure |
Denosumab 120 mg Q4W
n=37 participants at risk
Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
3/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
General disorders
Asthenia
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
General disorders
Fatigue
|
8.1%
3/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Bronchitis
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Influenza
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
3/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
3/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
4/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.9%
7/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Nervous system disorders
Headache
|
10.8%
4/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.4%
2/37 • up to 1 year 6 months
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
- Publication restrictions are in place
Restriction type: OTHER