Trial Outcomes & Findings for Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients (NCT NCT01129336)
NCT ID: NCT01129336
Last Updated: 2014-05-20
Results Overview
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
up to 18 months
Results posted on
2014-05-20
Participant Flow
80 patients were screened. 44 patients received treatment.
Participant milestones
| Measure |
Patients Without Bone Metastases
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
29
|
|
Overall Study
Completed Treatment
|
1
|
3
|
|
Overall Study
COMPLETED
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Patients Without Bone Metastases
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Missing Study Completion Status
|
2
|
3
|
|
Overall Study
Death
|
0
|
4
|
Baseline Characteristics
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Patients Without Bone Metastases
n=15 Participants
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 Participants
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.48 Years
STANDARD_DEVIATION 12.293 • n=5 Participants
|
59.47 Years
STANDARD_DEVIATION 14.535 • n=7 Participants
|
57.43 Years
STANDARD_DEVIATION 13.965 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthsPopulation: All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.
Outcome measures
| Measure |
Patients Without Bone Metastases
n=15 Participants
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 Participants
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Number of Participants With Progression Free Survival (PFS)
Event
|
9 Participants
|
19 Participants
|
|
Number of Participants With Progression Free Survival (PFS)
Censor
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 2, 4, 6, 9 and 18Population: All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. "n" in each category represents the number of patients with non-missing CTC values.
Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).
Outcome measures
| Measure |
Patients Without Bone Metastases
n=15 Participants
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 Participants
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Baseline (n=15,28)
|
26.7 Percentage of Participants
Interval 7.8 to 55.1
|
57.1 Percentage of Participants
Interval 37.2 to 75.5
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 1 (n=8,0)
|
12.5 Percentage of Participants
Interval 0.3 to 52.7
|
NA Percentage of Participants
No patient analyzed in this arm for month 1.
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 2 (n=12,24)
|
8.3 Percentage of Participants
Interval 0.2 to 38.5
|
25.0 Percentage of Participants
Interval 9.8 to 46.7
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 4 (n=8,20)
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
15.0 Percentage of Participants
Interval 3.2 to 37.9
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 6 (n=7,19)
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
15.8 Percentage of Participants
Interval 3.4 to 39.6
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 9 (n=2,14)
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
35.7 Percentage of Participants
Interval 12.8 to 64.9
|
|
Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
Month 18 (n=2,1)
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
100.0 Percentage of Participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.
Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.
Outcome measures
| Measure |
Patients Without Bone Metastases
n=15 Participants
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 Participants
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Time to Progression (TTP)
|
190 Days
Interval 118.0 to 478.0
|
297 Days
Interval 221.0 to 373.0
|
SECONDARY outcome
Timeframe: Baseline, Month 2, Month 4Population: All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.
NTX= N-telopeptide of type 1 collagen (nmol bce/mmol \[nanomoles of bone collagen equivalents per millimole of creatinine\]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.
Outcome measures
| Measure |
Patients Without Bone Metastases
n=15 Participants
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 Participants
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Change From Baseline in Urine NTX by Month
Change from baseline at Month 4
|
-4.750 nmol bce/mmol
Standard Deviation 18.7521
|
-23.476 nmol bce/mmol
Standard Deviation 26.3526
|
|
Change From Baseline in Urine NTX by Month
Change from baseline at Month 2
|
-5.25 nmol bce/mmol
Standard Deviation 22.5555
|
-27.619 nmol bce/mmol
Standard Deviation 23.3955
|
Adverse Events
Patients Without Bone Metastases
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Patients With Bone Metastases
Serious events: 7 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Without Bone Metastases
n=15 participants at risk
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 participants at risk
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15
|
0.00%
0/29
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
6.7%
1/15
|
0.00%
0/29
|
|
General disorders
Chest discomfort
|
0.00%
0/15
|
3.4%
1/29
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/15
|
3.4%
1/29
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/15
|
3.4%
1/29
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/15
|
3.4%
1/29
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15
|
3.4%
1/29
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15
|
3.4%
1/29
|
|
Infections and infestations
Sepsis
|
0.00%
0/15
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/15
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15
|
3.4%
1/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/15
|
3.4%
1/29
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/15
|
3.4%
1/29
|
|
Nervous system disorders
Convulsion
|
0.00%
0/15
|
3.4%
1/29
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/15
|
3.4%
1/29
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/15
|
3.4%
1/29
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/15
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/15
|
6.9%
2/29
|
Other adverse events
| Measure |
Patients Without Bone Metastases
n=15 participants at risk
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
|
Patients With Bone Metastases
n=29 participants at risk
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15
|
17.2%
5/29
|
|
Blood and lymphatic system disorders
Coagulopathy
|
6.7%
1/15
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
5/15
|
17.2%
5/29
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15
|
6.9%
2/29
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15
|
0.00%
0/29
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15
|
13.8%
4/29
|
|
Ear and labyrinth disorders
Deafness
|
6.7%
1/15
|
0.00%
0/29
|
|
Eye disorders
Erythema of eyelid
|
6.7%
1/15
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15
|
6.9%
2/29
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15
|
10.3%
3/29
|
|
Gastrointestinal disorders
Constipation
|
46.7%
7/15
|
6.9%
2/29
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15
|
13.8%
4/29
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15
|
10.3%
3/29
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15
|
6.9%
2/29
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15
|
0.00%
0/29
|
|
Gastrointestinal disorders
Lip ulceration
|
6.7%
1/15
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15
|
27.6%
8/29
|
|
Gastrointestinal disorders
Oedema mouth
|
6.7%
1/15
|
0.00%
0/29
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15
|
3.4%
1/29
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15
|
17.2%
5/29
|
|
General disorders
Asthenia
|
13.3%
2/15
|
6.9%
2/29
|
|
General disorders
Chest pain
|
6.7%
1/15
|
0.00%
0/29
|
|
General disorders
Chills
|
0.00%
0/15
|
13.8%
4/29
|
|
General disorders
Fatigue
|
26.7%
4/15
|
62.1%
18/29
|
|
General disorders
Generalised oedema
|
6.7%
1/15
|
0.00%
0/29
|
|
General disorders
Mucosal inflammation
|
13.3%
2/15
|
3.4%
1/29
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15
|
6.9%
2/29
|
|
General disorders
Oedema peripheral
|
20.0%
3/15
|
10.3%
3/29
|
|
General disorders
Pain
|
0.00%
0/15
|
10.3%
3/29
|
|
General disorders
Pyrexia
|
0.00%
0/15
|
17.2%
5/29
|
|
Hepatobiliary disorders
Jaundice
|
6.7%
1/15
|
0.00%
0/29
|
|
Immune system disorders
Drug hypersensitivity
|
6.7%
1/15
|
3.4%
1/29
|
|
Infections and infestations
Acute sinusitis
|
6.7%
1/15
|
0.00%
0/29
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15
|
0.00%
0/29
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15
|
0.00%
0/29
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15
|
6.9%
2/29
|
|
Infections and infestations
Postoperative wound infection
|
6.7%
1/15
|
0.00%
0/29
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15
|
10.3%
3/29
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15
|
3.4%
1/29
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.7%
1/15
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
6.7%
1/15
|
0.00%
0/29
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15
|
6.9%
2/29
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15
|
6.9%
2/29
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15
|
6.9%
2/29
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15
|
20.7%
6/29
|
|
Investigations
Haemoglobin decreased
|
6.7%
1/15
|
10.3%
3/29
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15
|
6.9%
2/29
|
|
Investigations
Platelet count decreased
|
6.7%
1/15
|
0.00%
0/29
|
|
Investigations
Urine output decreased
|
6.7%
1/15
|
0.00%
0/29
|
|
Investigations
Weight decreased
|
0.00%
0/15
|
6.9%
2/29
|
|
Investigations
Weight increased
|
6.7%
1/15
|
0.00%
0/29
|
|
Investigations
White blood cell count decreased
|
0.00%
0/15
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15
|
13.8%
4/29
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15
|
17.2%
5/29
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
1/15
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15
|
10.3%
3/29
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.7%
1/15
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15
|
24.1%
7/29
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15
|
31.0%
9/29
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
2/15
|
17.2%
5/29
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
1/15
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15
|
13.8%
4/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
3/15
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15
|
10.3%
3/29
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.7%
1/15
|
0.00%
0/29
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15
|
10.3%
3/29
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15
|
3.4%
1/29
|
|
Nervous system disorders
Headache
|
6.7%
1/15
|
10.3%
3/29
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15
|
6.9%
2/29
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
3/15
|
6.9%
2/29
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/15
|
6.9%
2/29
|
|
Nervous system disorders
Sinus headache
|
6.7%
1/15
|
0.00%
0/29
|
|
Nervous system disorders
Tremor
|
6.7%
1/15
|
0.00%
0/29
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15
|
10.3%
3/29
|
|
Psychiatric disorders
Depression
|
6.7%
1/15
|
10.3%
3/29
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15
|
13.8%
4/29
|
|
Psychiatric disorders
Sleep disorder
|
6.7%
1/15
|
0.00%
0/29
|
|
Renal and urinary disorders
Bladder irritation
|
6.7%
1/15
|
0.00%
0/29
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15
|
20.7%
6/29
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
1/15
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.7%
4/15
|
13.8%
4/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
6.7%
1/15
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
6.7%
1/15
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
1/15
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/15
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
13.3%
2/15
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.7%
1/15
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
6.7%
1/15
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15
|
6.9%
2/29
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15
|
6.9%
2/29
|
|
Vascular disorders
Flushing
|
6.7%
1/15
|
0.00%
0/29
|
|
Vascular disorders
Hot flush
|
13.3%
2/15
|
17.2%
5/29
|
|
Vascular disorders
Hypertension
|
6.7%
1/15
|
3.4%
1/29
|
|
Vascular disorders
Hypotension
|
0.00%
0/15
|
10.3%
3/29
|
|
Vascular disorders
Lymphoedema
|
6.7%
1/15
|
0.00%
0/29
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER