Trial Outcomes & Findings for Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only (NCT NCT00950911)
NCT ID: NCT00950911
Last Updated: 2014-02-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
2 years
Results posted on
2014-02-11
Participant Flow
Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom.
Participant milestones
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
4
|
6
|
|
Overall Study
Disease progression
|
2
|
2
|
|
Overall Study
Consent withdrawn
|
1
|
3
|
|
Overall Study
Administrative decision
|
3
|
1
|
|
Overall Study
Ineligibility determined
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
0
|
|
Overall Study
Poor performance status
|
0
|
1
|
Baseline Characteristics
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Baseline characteristics by cohort
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
n=17 Participants
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
n=18 Participants
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
61.1 Years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
61.3 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Full Analysis Set
Outcome measures
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
n=17 Participants
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
n=18 Participants
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
|---|---|---|
|
Number of Participants Survived
|
13 Participants
|
12 Participants
|
Adverse Events
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
Serious events: 10 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
n=17 participants at risk
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
n=18 participants at risk
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Death
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Cachexia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
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)
Metastases to meninges
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
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)
Neoplasm malignant
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
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)
Prostate cancer metastatic
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Hip arthroplasty
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Jugular vein thrombosis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W
n=17 participants at risk
This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
Denosumab 120 mg Q4W / Denosumab 120 mg Q4W
n=18 participants at risk
This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
33.3%
6/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
3/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Endocrine disorders
Cushingoid
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye pain
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye swelling
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
4/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Duodenitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
27.8%
5/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral disorder
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Tooth loss
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
3/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Face oedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Facial pain
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
17.6%
3/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
33.3%
6/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Feeling hot
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Gait disturbance
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
General physical health deterioration
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Local swelling
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Localised oedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Mucosal necrosis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Submandibular mass
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Swelling
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Liver disorder
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Immunodeficiency
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Borrelia infection
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cystitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Herpes zoster
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Localised infection
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral fungal infection
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pharyngitis
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
4/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.5%
4/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
4/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.6%
3/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
3/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
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)
Basal cell carcinoma
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
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)
Tumour flare
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Brain oedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Lethargy
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Penile oedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
3/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
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%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
2/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity allergic reaction
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.6%
1/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Social circumstances
Denture wearer
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Tooth extraction
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Lymphoedema
|
5.9%
1/17 • 2 years
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/18 • 2 years
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 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