Trial Outcomes & Findings for Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer (NCT NCT01419717)
NCT ID: NCT01419717
Last Updated: 2019-09-24
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where 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. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Results posted on
2019-09-24
Participant Flow
This study was conducted at 65 centers in Europe, Latin America, Japan, and South Africa. Participants were enrolled from 22 November 2011 to 27 October 2014.
Participant milestones
| Measure |
Denosumab
Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
Received Denosumab
|
128
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
| Measure |
Denosumab
Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Overall Study
Protocol-specified Criteria
|
62
|
|
Overall Study
Adverse Event
|
19
|
|
Overall Study
Death
|
17
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Other
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Administrative Decision
|
1
|
|
Overall Study
Noncompliance
|
1
|
Baseline Characteristics
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Denosumab
n=129 Participants
Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Age, Continuous
|
65.74 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
|
Age, Customized
18 - 64 years
|
60 Participants
n=5 Participants
|
|
Age, Customized
65 - 74 years
|
36 Participants
n=5 Participants
|
|
Age, Customized
75 - 84 years
|
28 Participants
n=5 Participants
|
|
Age, Customized
≥ 85 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.Population: All participants who received at least one dose of denosumab in study 20110113
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where 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. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
Outcome measures
| Measure |
Denosumab
n=128 Participants
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Number of Participants With Adverse Events
AE leading to discontinuation of denosumab
|
28 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation from study
|
22 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
18 Participants
|
|
Number of Participants With Adverse Events
AE grade 3, 4, or 5
|
46 Participants
|
|
Number of Participants With Adverse Events
Treatment-related fatal adverse events
|
0 Participants
|
|
Number of Participants With Adverse Events
Treatment-related AE grade 3, 4, or 5
|
8 Participants
|
|
Number of Participants With Adverse Events
All adverse events
|
98 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
45 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse event
|
26 Participants
|
|
Number of Participants With Adverse Events
Treatment-related serious adverse event
|
10 Participants
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation of denosumab
|
18 Participants
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation from study
|
16 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.Population: Participants who received at least 1 dose of denosumab in study 20110113 and with at least 1 antibody sample tested.
A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Outcome measures
| Measure |
Denosumab
n=86 Participants
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Number of Participants With Anti-denosumab Binding Antibodies
|
0 Participants
|
Adverse Events
Denosumab
Serious events: 45 serious events
Other events: 66 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Denosumab
n=128 participants at risk
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
3/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Melaena
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
General physical health deterioration
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Jaundice
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess jaw
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Myelitis
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
2.3%
3/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
3.1%
4/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulpitis dental
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
5.5%
7/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraplegia
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Radiculopathy
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
3/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.78%
1/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
2/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Denosumab
n=128 participants at risk
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
8/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
9/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
11/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
11.7%
15/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
7.0%
9/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
11/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
11.7%
15/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
9.4%
12/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.9%
14/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
15/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
16/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
6.2%
8/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.2%
13/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
7/128 • From first dose of denosumab in Study 20110113 to end of study. Median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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Additional Information
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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER