Trial Outcomes & Findings for Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab (NCT NCT00259740)
NCT ID: NCT00259740
Last Updated: 2017-03-15
Results Overview
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2017-03-15
Participant Flow
Participants were enrolled from 13 February 2006 through 8 December 2006
Participant milestones
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
53
|
|
Overall Study
Received Study Medication
|
42
|
53
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
53
|
Reasons for withdrawal
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Disease progression
|
19
|
36
|
|
Overall Study
Ongoing
|
17
|
3
|
|
Overall Study
Other
|
3
|
0
|
|
Overall Study
Requirement for alternative therapy
|
0
|
4
|
Baseline Characteristics
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Baseline characteristics by cohort
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
n=43 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
n=53 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: All participants who completed the first cycle of treatment with denosumab
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
Outcome measures
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
n=41 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
n=53 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
|---|---|---|
|
Complete Response or Partial Response Based on M-Protein Assessments Only
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: All participants who completed the first cycle of treatment with denosumab
Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.
Outcome measures
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
n=41 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
n=53 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
|---|---|---|
|
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: All participants who completed the first cycle of treatment with denosumab
Complete response based on M-protein assessments, as defined for the primary outcome measure.
Outcome measures
| Measure |
Denosumab 120 mg Q4W - Plateau-Phase
n=41 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
|
Denosumab 120 mg Q4W - Relapsed
n=53 Participants
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
|
|---|---|---|
|
Complete Response Based on M-Protein Assessments Only
|
0 Participants
|
0 Participants
|
Adverse Events
Denosumab 120 mg Q4W - Relapsed
Serious events: 14 serious events
Other events: 38 other events
Deaths: 0 deaths
Denosumab 120 mg Q4W - Plateau-Phase
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Denosumab 120 mg Q4W - Relapsed
n=53 participants at risk
|
Denosumab 120 mg Q4W - Plateau-Phase
n=42 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
2/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
2/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Catheter related infection
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lobar pneumonia
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia streptococcal
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Body temperature increased
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
3.8%
2/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
3.8%
2/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
1/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Denosumab 120 mg Q4W - Relapsed
n=53 participants at risk
|
Denosumab 120 mg Q4W - Plateau-Phase
n=42 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
8/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
7/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
6/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
15.1%
8/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.0%
8/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.9%
5/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.0%
9/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
12/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
7/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
7/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.4%
5/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
7/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.0%
8/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Lethargy
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
7.5%
4/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
6/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
3/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.5%
4/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
3/42 • up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
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 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.
- Publication restrictions are in place
Restriction type: OTHER