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An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis (4EVERUK)

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ClinicalTrials.gov Identifier: NCT01743560
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : April 1, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Oestrogen Receptor Positive Advanced Breast Cancer
Interventions Drug: RAD001
Drug: Exemestane
Enrollment 52
Recruitment Details  
Pre-assignment Details Sixty-seven patients were screened and 52 patients were enrolled.
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Period Title: Overall Study
Started 52
Full Analysis Set (FAS) 49 [1]
Safety Analysis Set (SAF) 49 [2]
Completed 9
Not Completed 43
Reason Not Completed
Disease progression             26
Adverse Event             8
Death             3
Withdrawal by Subject             2
Protocol Violation             1
>1 dose of study drug             3
[1]
≥ 1 dose study drug
[2]
≥ 1 dose study drug +1 post baseline safety assessment
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
FAS
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
61.3  (8.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
49
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Caucasian
48
  98.0%
Other
1
   2.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 49 participants
71.1  (15.44)
1.Primary Outcome
Title Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
Hide Description The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.
Time Frame At 48 weeks
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Hide Analysis Population Description
FAS
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
Patients with measurable disease at baseline 39
Patients with non-measurable disease at baseline 10
Best at WK 48 - Complete Response (CR) 0
Best at WK 48 - Partial Response (PR) 7
Best at WK 48 - Stable Disease (SD) 18
Best at WK 48 - Progressive Disease (PD) 15
Unknown 1
Missing 8
2.Primary Outcome
Title Overall Response Rate of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
Hide Description The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48. Treatment success is defined as: The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.
Time Frame At 48 weeks
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Hide Analysis Population Description
FAS
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.3
(6.0 to 27.0)
3.Secondary Outcome
Title Progression-free Survival (PFS) Events as Per Investigators - FAS
Hide Description Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.
Time Frame Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Number of events
Deaths 8
Progression of disease 25
Number of censored observations 16
4.Secondary Outcome
Title Progression-free Survival (PFS) by Median Time in Weeks as Per Investigators - FAS
Hide Description Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.
Time Frame Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: weeks
23.6
(12.71 to 34.29)
5.Secondary Outcome
Title Progression-free Survival (PFS) - % Event-free Probability Estimate - FAS
Hide Description Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review. The PFS was analyzed using the Kaplan Meier method.
Time Frame Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Event free at 12 weeks
67.9
(51.82 to 79.56)
Event free at 24 weeks
49.1
(32.98 to 63.44)
Event free at 36 weeks
28.9
(15.42 to 43.87)
Event free at 48 weeks
18.4
(7.38 to 33.19)
6.Secondary Outcome
Title Overall Survival (OS) Events (Number of Deaths) - FAS
Hide Description Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. Time to median OS was not estimable.
Time Frame Start of treatment to the date of death up to approximately 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Number of events
Deaths 8
Number of censored observations 41
7.Secondary Outcome
Title Overall Survival (OS) - % Event-free Probability Estimate - FAS
Hide Description Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
Time Frame Start of treatment to the date of death up to approximately 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Everolimus and Exemestane
Hide Arm/Group Description:
Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Event free at 12 weeks
93.3
(80.57 to 97.78)
Event free at 24 weeks
83.9
(66.92 to 92.60)
Event free at 36 weeks
74.2
(53.02 to 86.88)
Event free at 48 weeks
74.2
(53.02 to 86.88)
8.Secondary Outcome
Title Change From Baseline EORTC Quality of Life Questionnaire of Cancer Patients QLQ-C30 at Each Time Point
Hide Description The QLQ-C30 is composed of multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status-QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. High scale score=higher response level; a high score for a functional scale=a healthy level of function, high score for the global health status/QoL=high quality of life but a high score for a symptom scale / item=high level of symptomatology/problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations
Time Frame Baseline 12,24,36,48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
number of participants varied across visits
Arm/Group Title Week 12 Week 24 Week 36 Week 48
Hide Arm/Group Description:
Change from baseline at week 12
Change from baseline at Week 24
Change from baseline at week 36
Change from baseline at week 48
Overall Number of Participants Analyzed 27 17 13 28
Mean (Standard Deviation)
Unit of Measure: scores
Global health status/QoL Number Analyzed 27 participants 16 participants 13 participants 26 participants
-9.0  (22.04) -3.6  (19.71) 1.9  (16.37) -8.3  (22.48)
Physical functioning Number Analyzed 27 participants 17 participants 13 participants 28 participants
-5.1  (19.16) -1.0  (14.52) 4.9  (13.79) -10.8  (29.97)
Role functioning Number Analyzed 26 participants 16 participants 12 participants 27 participants
-4.5  (33.19) 3.1  (23.74) 8.3  (23.03) -12.3  (30.52)
Emotional functioning Number Analyzed 27 participants 16 participants 13 participants 26 participants
2.6  (21.36) -3.1  (14.87) 7.5  (9.90) 0.6  (21.59)
Cognitive functioning Number Analyzed 27 participants 16 participants 13 participants 27 participants
-8.6  (21.37) -5.2  (17.97) 1.3  (22.01) -3.7  (21.35)
Social functioning Number Analyzed 27 participants 16 participants 13 participants 26 participants
-9.9  (25.00) -9.4  (24.32) 3.8  (15.45) -14.7  (31.74)
Fatigue Number Analyzed 27 participants 17 participants 13 participants 28 participants
8.6  (26.92) 9.5  (15.93) 0.9  (16.64) 7.3  (24.66)
Nausea/ vomiting Number Analyzed 27 participants 17 participants 13 participants 28 participants
-1.2  (15.96) 2.9  (16.91) -3.8  (15.45) -2.4  (23.88)
Pain Number Analyzed 27 participants 17 participants 13 participants 28 participants
1.2  (26.12) 3.9  (24.67) -1.3  (20.93) 0.6  (24.64)
Dyspnea Number Analyzed 27 participants 16 participants 13 participants 28 participants
18.5  (37.36) 8.3  (25.82) 2.6  (25.32) 10.7  (27.30)
Insomnia Number Analyzed 27 participants 17 participants 13 participants 28 participants
3.7  (26.69) 2.0  (29.98) 0  (23.57) -3.6  (37.78)
Appetite loss Number Analyzed 27 participants 17 participants 13 participants 28 participants
30.9  (40.22) 23.5  (28.30) 12.8  (28.99) 16.7  (35.72)
Constipation Number Analyzed 27 participants 17 participants 13 participants 28 participants
4.9  (32.95) 11.8  (28.73) 10.3  (21.01) 8.3  (19.51)
Diarrhea Number Analyzed 27 participants 16 participants 13 participants 27 participants
4.9  (25.66) 8.3  (37.52) -5.1  (22.96) 7.4  (28.24)
Financial problems Number Analyzed 27 participants 16 participants 13 participants 26 participants
-1.2  (21.64) -10.4  (26.44) -10.3  (21.01) -2.6  (18.67)
9.Secondary Outcome
Title Percentage of Patient Responses in EuroQoL 5-dimension Questionnaire - FAS
Hide Description EuroQoL Quality of Life Scale (EQ-5D) is a standardized instrument to assess health state values is a standardized instrument to assess health state values. The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The EQ-5D descriptive system is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Percentage of participants' responses were presented by visits. Results should be interpreted with caution as the numbers of patients with available data over time were limited.
Time Frame Baseline 12,24,36,48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Day 1 Week 12 Week 24 Week 36 Week 48
Hide Arm/Group Description:
Baseline
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 49 49 49 49 49
Measure Type: Number
Unit of Measure: Percentage of participants
Mobility-no problem 38.8 20.4 18.4 14.3 16.3
Mobility-slight problem 18.4 14.3 10.2 8.2 16.3
Mobility-moderate problem 32.7 20.4 8.2 2.0 14.3
Mobility-severe problem 6.1 2.0 0 2.0 6.1
Mobility-unable to walk 0 0 0 0 4.1
Self-care - no problem 69.4 44.9 34.7 24.5 40.8
Self-care - slight problem 18.4 4.1 0 0 10.2
Self-care - moderate problem 6.1 8.2 2.0 2.0 4.1
Self-care -severe problem 2.0 0 0 0 2.0
Self-care - unable 0 0 0 0 0
Usual activities - no problems 30.6 14.3 22.4 14.3 18.4
Usual activities - slight problems 22.4 16.3 2.0 8.2 14.3
Usual activities - moderate problems 28.6 22.4 12.2 2.0 12.2
Usual activities - severe problems 10.2 4.1 0 2.0 6.1
Usual activities -unable to do 4.1 0 0 0 6.1
Pain/discomfort - none 20.4 14.3 10.2 12.2 18.4
Pain/discomfort - slight 30.6 16.3 18.4 8.2 20.4
Pain/discomfort - moderate 40.8 22.4 8.2 6.1 14.3
Pain/discomfort - severe 4.1 4.1 0 0 4.1
Pain/discomfort - extreme 0 0 0 0 0
Anxiety/depression - none 44.9 22.4 18.4 16.3 22.4
Anxiety/depression - slight 34.7 22.4 12.2 10.2 20.4
Anxiety/depression - moderate 16.3 12.2 6.1 0 8.2
Anxiety/depression - severe 0 0 0 0 6.1
Anxiety/depression - extreme 0 0 0 0 0
10.Secondary Outcome
Title Change From Baseline in EuroQoL 5-dimension Visual Analogue Scores - FAS
Hide Description EuroQoL Quality of Life Scale (EQ-5D) is a standardized instrument to assess health state values. The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state). Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). Scores for the visual analogue scale reflect the position where participant's line crosses the thermometer-like scale. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations
Time Frame Baseline 12,24,36,48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Week 12 Week 24 Week 36 Week 48
Hide Arm/Group Description:
Change from baseline at week 12
Change from baseline at Week 24
Change from baseline at week 36
Change from baseline at week 48
Overall Number of Participants Analyzed 25 16 12 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.9  (18.98) -6.1  (12.47) -6.3  (10.03) -11.6  (22.58)
Time Frame Adverse Events (AEs) are collected from the First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Adverse Event Reporting Description Consistent with EudracCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
 
Arm/Group Title Everolimus + Exemestane
Hide Arm/Group Description Everolimus + Exemestane
All-Cause Mortality
Everolimus + Exemestane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Everolimus + Exemestane
Affected / at Risk (%)
Total   22/49 (44.90%) 
Blood and lymphatic system disorders   
Anaemia  1  2/49 (4.08%) 
Cardiac disorders   
Pericardial effusion  1  1/49 (2.04%) 
Tachycardia  1  1/49 (2.04%) 
Gastrointestinal disorders   
Abdominal pain  1  1/49 (2.04%) 
Abdominal pain upper  1  1/49 (2.04%) 
Colitis  1  1/49 (2.04%) 
Duodenal ulcer  1  1/49 (2.04%) 
Gastric ulcer  1  1/49 (2.04%) 
Haematemesis  1  1/49 (2.04%) 
Oral pain  1  1/49 (2.04%) 
Vomiting  1  2/49 (4.08%) 
General disorders   
Mucosal inflammation  1  1/49 (2.04%) 
Infections and infestations   
Lower respiratory tract infection  1  4/49 (8.16%) 
Pneumonia  1  1/49 (2.04%) 
Urinary tract infection  1  1/49 (2.04%) 
Injury, poisoning and procedural complications   
Fall  1  1/49 (2.04%) 
Overdose  1  1/49 (2.04%) 
Metabolism and nutrition disorders   
Dehydration  1  1/49 (2.04%) 
Hypercalcaemia  1  2/49 (4.08%) 
Hyperglycaemia  1  2/49 (4.08%) 
Hyperkalaemia  1  1/49 (2.04%) 
Hypoglycaemia  1  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/49 (2.04%) 
Muscular weakness  1  1/49 (2.04%) 
Musculoskeletal chest pain  1  1/49 (2.04%) 
Pain in extremity  1  1/49 (2.04%) 
Nervous system disorders   
Hemiparesis  1  1/49 (2.04%) 
Lethargy  1  1/49 (2.04%) 
Neuropathy peripheral  1  1/49 (2.04%) 
Seizure  1  1/49 (2.04%) 
Somnolence  1  1/49 (2.04%) 
Spinal cord compression  1  2/49 (4.08%) 
Psychiatric disorders   
Confusional state  1  3/49 (6.12%) 
Renal and urinary disorders   
Renal failure  1  2/49 (4.08%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/49 (2.04%) 
Epistaxis  1  1/49 (2.04%) 
Non-cardiogenic pulmonary oedema  1  1/49 (2.04%) 
Pneumonitis  1  2/49 (4.08%) 
Pulmonary embolism  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus + Exemestane
Affected / at Risk (%)
Total   49/49 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  8/49 (16.33%) 
Thrombocytopenia  1  4/49 (8.16%) 
Gastrointestinal disorders   
Abdominal distension  1  3/49 (6.12%) 
Abdominal pain  1  5/49 (10.20%) 
Constipation  1  8/49 (16.33%) 
Diarrhoea  1  22/49 (44.90%) 
Dry mouth  1  4/49 (8.16%) 
Dyspepsia  1  5/49 (10.20%) 
Mouth ulceration  1  11/49 (22.45%) 
Nausea  1  14/49 (28.57%) 
Oral pain  1  6/49 (12.24%) 
Stomatitis  1  7/49 (14.29%) 
Vomiting  1  8/49 (16.33%) 
General disorders   
Axillary pain  1  4/49 (8.16%) 
Fatigue  1  22/49 (44.90%) 
Mucosal inflammation  1  17/49 (34.69%) 
Oedema peripheral  1  3/49 (6.12%) 
Peripheral swelling  1  3/49 (6.12%) 
Infections and infestations   
Lower respiratory tract infection  1  4/49 (8.16%) 
Oral candidiasis  1  5/49 (10.20%) 
Urinary tract infection  1  6/49 (12.24%) 
Investigations   
Alanine aminotransferase increased  1  4/49 (8.16%) 
Aspartate aminotransferase increased  1  4/49 (8.16%) 
Blood cholesterol increased  1  3/49 (6.12%) 
Blood creatinine increased  1  4/49 (8.16%) 
Gamma-glutamyltransferase increased  1  6/49 (12.24%) 
Weight decreased  1  6/49 (12.24%) 
Metabolism and nutrition disorders   
Decreased appetite  1  16/49 (32.65%) 
Hypercalcaemia  1  4/49 (8.16%) 
Hyperglycaemia  1  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/49 (6.12%) 
Back pain  1  6/49 (12.24%) 
Joint swelling  1  3/49 (6.12%) 
Musculoskeletal pain  1  5/49 (10.20%) 
Pain in extremity  1  7/49 (14.29%) 
Nervous system disorders   
Dysgeusia  1  7/49 (14.29%) 
Headache  1  3/49 (6.12%) 
Psychiatric disorders   
Depressed mood  1  4/49 (8.16%) 
Insomnia  1  4/49 (8.16%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  18/49 (36.73%) 
Dyspnoea  1  11/49 (22.45%) 
Epistaxis  1  8/49 (16.33%) 
Oropharyngeal pain  1  3/49 (6.12%) 
Pneumonitis  1  3/49 (6.12%) 
Productive cough  1  3/49 (6.12%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  6/49 (12.24%) 
Rash  1  18/49 (36.73%) 
Vascular disorders   
Lymphoedema  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01743560     History of Changes
Other Study ID Numbers: CRAD001YGB11
2012-003689-41 ( EudraCT Number )
First Submitted: October 24, 2012
First Posted: December 6, 2012
Results First Submitted: August 14, 2017
Results First Posted: April 1, 2019
Last Update Posted: July 18, 2019