Trial Outcomes & Findings for A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer (NCT NCT00171704)

NCT ID: NCT00171704

Last Updated: 2017-03-03

Results Overview

Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 263 participants
• Primary outcome timeframe: Baseline, 24 months
• Results posted on: 2017-03-03

Participant Flow

Participant milestones

Measure	Letrozole 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Overall Study STARTED	133	130
Overall Study COMPLETED	89	81
Overall Study NOT COMPLETED	44	49

Reasons for withdrawal

Measure	Letrozole 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Overall Study Adverse Event	24	33
Overall Study Disease Progression	14	9
Overall Study New therapy for 2nd non-breast prim canc	1	0
Overall Study Administrative Problems	2	1
Overall Study Death	2	2
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Baseline characteristics by cohort

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.	Total n=263 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 6.1 • n=93 Participants	61.8 years STANDARD_DEVIATION 6.2 • n=4 Participants	61.6 years STANDARD_DEVIATION 6.2 • n=27 Participants
Sex: Female, Male Female	133 Participants n=93 Participants	130 Participants n=4 Participants	263 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 24 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients in each treatment arm who had completed 2 years of the study and had centrally assessed measurements of lumbar spine or total hip BMD.

Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.

Outcome measures

Measure	Letrozole n=63 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=68 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)	-4.63 Percent Change Interval -14.21 to 4.32	0.37 Percent Change Interval -6.98 to 15.21

SECONDARY outcome

Timeframe: Baseline, 60 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. The analysis at 5 years included all patients enrolled and who had centrally assessed measurements of lumbar spine and/or total hip BMD.

Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.

Outcome measures

Measure	Letrozole n=56 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=53 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine	-5.66 Percent change Interval -15.06 to 5.11	-3.3 Percent change Interval -13.48 to 4.92

SECONDARY outcome

Timeframe: Baseline, 60 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. The analysis of BMD at 5 years included all patients enrolled with centrally assessed measurements of total hip BMD.

Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.

Outcome measures

Measure	Letrozole n=62 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=65 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip	-5.77 Percent Change Interval -22.53 to 12.53	-3.98 Percent Change Interval -13.6 to 5.57

SECONDARY outcome

Timeframe: Baseline, 60 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis. The analysis of bone markers over time consisted of patients with measurements of specific markers at each time point.

Bone turnover markers (fasting serum procollagen-I extension peptide [P1NP], C-telopeptide [CTX], skeletal bone-specific alkaline phosphatase [BSAP, N-telopeptide [NTX]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.

Outcome measures

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Median Percent Change From Baseline of Serum Markers of Bone Turnover Procollagen-I (PINP) (n=86, 78)	-14.15 Percent Change Interval -78.5 to 177.8	-0.5 Percent Change Interval -84.8 to 200.0
Median Percent Change From Baseline of Serum Markers of Bone Turnover Bone Specific alkaline Phosphatase (n=87,78)	16.2 Percent Change Interval -53.6 to 192.6	19.15 Percent Change Interval -58.0 to 237.8
Median Percent Change From Baseline of Serum Markers of Bone Turnover C-telopeptide (CTX) (n=88, 78)	-12.05 Percent Change Interval -80.9 to 130.6	4.55 Percent Change Interval -81.2 to 236.8
Median Percent Change From Baseline of Serum Markers of Bone Turnover N-telopeptide (NTX) (n=-88, 77)	-53.05 Percent Change Interval -86.3 to 20.2	-50.7 Percent Change Interval -100.0 to 39.0

SECONDARY outcome

Timeframe: Baseline, 60 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis.

Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.

Outcome measures

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Percentage Change From Baseline in Serum Lipids at 5 Years Total Cholesterol (n=91, 82)	-7.3 Percent Change Full Range 17.64 • Interval -45.2 to 34.7	-2.45 Percent Change Full Range 16.63 • Interval -55.7 to 24.5
Percentage Change From Baseline in Serum Lipids at 5 Years LDL Cholesterol (n=91, 82)	-12.7 Percent Change Full Range 24.947 • Interval -63.9 to 58.3	-11.05 Percent Change Full Range 23.958 • Interval -65.0 to 48.4
Percentage Change From Baseline in Serum Lipids at 5 Years HDL Cholesterol (n=91, 82)	8.7 Percent Change Full Range 16.388 • Interval -40.0 to 60.0	8.9 Percent Change Full Range -38.5 • Interval -38.5 to 68.8

SECONDARY outcome

Timeframe: Baseline, 60 months

Population: The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients with pre-defined clinically relevant changes in serum lipids over the course of 5 years in each treatment arm is presented.

Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.

Outcome measures

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol Patients with one or more change	30 Participants	21 Participants
Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol ≥8 mmol/L total (T) cholesterol	7 Participants	5 Participants
Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol ≥7 mmol/L T.choles. & ≥1 risk for cardiac disease	18 Participants	12 Participants
Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol ≥6 mmol/L T. choles. & ≥2 risk for cardiac disease	11 Participants	9 Participants

SECONDARY outcome

Timeframe: 60 months

Population: Analysis of disease-free survival was based on the ITT principle, with all enrolled (and randomized) patients included. The Kaplan-Meier product-limit approach was used.

Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.

Outcome measures

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Time to Disease Recurrence or Death	NA Days Median time to disease recurrence or death was not achieved, nor was it possible to estimate 25% or 75th percentile for disease free survival.	NA Days Median time to disease recurrence or death was not achieved, nor was it possible to estimate 25% or 75th percentile for disease free survival.

SECONDARY outcome

Timeframe: 60 Months

Population: All randomized patients constituted the ITT Population, unless withdrawal of consent occurred after randomization but before the start of study treatment assigned.

Overall survival was measured from date of randomization to date of death.

Outcome measures

Measure	Letrozole n=133 Participants 2.5 mg once daily (q.d.)orally for 5 years	Tam-Let n=130 Participants 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Time to Overall Survival Events	NA days Median time to death was not achieved; nor was it possible to estimate 25th or 75th percentile for overall survival.	NA days Median time to death was not achieved; nor was it possible to estimate 25th or 75th percentile for overall survival.

Adverse Events

Letrozole

Serious events: 50 serious events

Other events: 113 other events

Deaths: 0 deaths

Tam-Let

Serious events: 41 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Measure	Letrozole n=133 participants at risk 2.5 mg once daily q.d. orally for 5 years	Tam-Let n=130 participants at risk 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Cardiac disorders Acute myocardial infarction	0.00% 0/133	1.5% 2/130
Cardiac disorders Angina pectoris	0.75% 1/133	0.77% 1/130
Cardiac disorders Angina unstable	0.00% 0/133	0.77% 1/130
Cardiac disorders Arrhythmia	0.75% 1/133	0.00% 0/130
Cardiac disorders Atrial fibrillation	1.5% 2/133	1.5% 2/130
Cardiac disorders Atrial flutter	0.00% 0/133	0.77% 1/130
Cardiac disorders Bundle branch block left	0.75% 1/133	0.00% 0/130
Cardiac disorders Myocardial infarction	0.00% 0/133	0.77% 1/130
Cardiac disorders Pericarditis	0.00% 0/133	0.77% 1/130
Cardiac disorders Sinus bradycardia	0.00% 0/133	0.77% 1/130
Endocrine disorders Goitre	0.75% 1/133	0.00% 0/130
Eye disorders Retinal detachment	1.5% 2/133	0.00% 0/130
Gastrointestinal disorders Abdominal hernia	0.00% 0/133	0.77% 1/130
Gastrointestinal disorders Abdominal pain	0.00% 0/133	0.77% 1/130
Gastrointestinal disorders Ascites	0.00% 0/133	0.77% 1/130
Gastrointestinal disorders Colitis	0.00% 0/133	0.77% 1/130
Gastrointestinal disorders Diarrhoea	0.75% 1/133	0.00% 0/130
Gastrointestinal disorders Diverticulum	0.75% 1/133	0.00% 0/130
Gastrointestinal disorders Pancreatitis acute	0.75% 1/133	0.00% 0/130
Gastrointestinal disorders Vomiting	0.75% 1/133	0.00% 0/130
General disorders Medical device complication	0.75% 1/133	0.00% 0/130
General disorders Oedema peripheral	0.00% 0/133	0.77% 1/130
General disorders Pyrexia	0.75% 1/133	0.00% 0/130
Hepatobiliary disorders Cholelithiasis	0.75% 1/133	0.77% 1/130
Infections and infestations Breast infection	0.00% 0/133	1.5% 2/130
Infections and infestations Bronchitis	0.00% 0/133	0.77% 1/130
Infections and infestations Cystitis	0.00% 0/133	0.77% 1/130
Infections and infestations Diverticulitis	2.3% 3/133	0.00% 0/130
Infections and infestations Encephalitis herpes	0.75% 1/133	0.00% 0/130
Infections and infestations Erysipelas	0.75% 1/133	1.5% 2/130
Infections and infestations Herpes zoster	0.00% 0/133	0.77% 1/130
Infections and infestations Infection	0.75% 1/133	0.00% 0/130
Infections and infestations Pneumonia	3.0% 4/133	0.77% 1/130
Infections and infestations Skin infection	1.5% 2/133	0.00% 0/130
Infections and infestations Upper respiratory tract infection	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Ankle fracture	1.5% 2/133	0.77% 1/130
Injury, poisoning and procedural complications Femoral neck fracture	0.75% 1/133	0.77% 1/130
Injury, poisoning and procedural complications Femur fracture	0.00% 0/133	0.77% 1/130
Injury, poisoning and procedural complications Humerus fracture	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/133	0.77% 1/130
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Radius fracture	1.5% 2/133	0.77% 1/130
Injury, poisoning and procedural complications Rib fracture	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/133	0.77% 1/130
Injury, poisoning and procedural complications Subdural haematoma	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Tendon rupture	0.75% 1/133	0.00% 0/130
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/133	0.77% 1/130
Investigations Blood alkaline phosphatase increased	0.75% 1/133	0.00% 0/130
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/133	0.77% 1/130
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/133	1.5% 2/130
Musculoskeletal and connective tissue disorders Arthritis	0.75% 1/133	0.00% 0/130
Musculoskeletal and connective tissue disorders Back pain	0.75% 1/133	0.00% 0/130
Musculoskeletal and connective tissue disorders Bone pain	0.75% 1/133	0.00% 0/130
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.75% 1/133	0.00% 0/130
Musculoskeletal and connective tissue disorders Osteoarthritis	3.8% 5/133	3.1% 4/130
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/133	1.5% 2/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	1.5% 2/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.75% 1/133	0.77% 1/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.75% 1/133	1.5% 2/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.00% 0/133	0.77% 1/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.75% 1/133	1.5% 2/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/133	0.77% 1/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	2.3% 3/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.75% 1/133	0.00% 0/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/133	1.5% 2/130
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.75% 1/133	0.00% 0/130
Nervous system disorders Cerebral infarction	0.75% 1/133	0.00% 0/130
Nervous system disorders Cerebrovascular accident	0.00% 0/133	1.5% 2/130
Nervous system disorders Dizziness	0.75% 1/133	0.00% 0/130
Nervous system disorders Headache	0.75% 1/133	0.00% 0/130
Psychiatric disorders Depression	0.75% 1/133	0.00% 0/130
Renal and urinary disorders Calculus ureteric	0.75% 1/133	0.00% 0/130
Reproductive system and breast disorders Colpocele	1.5% 2/133	0.00% 0/130
Reproductive system and breast disorders Cystocele	0.00% 0/133	0.77% 1/130
Reproductive system and breast disorders Ovarian cyst	0.75% 1/133	0.00% 0/130
Reproductive system and breast disorders Rectocele	0.00% 0/133	0.77% 1/130
Reproductive system and breast disorders Uterine polyp	0.75% 1/133	0.00% 0/130
Reproductive system and breast disorders Uterine prolapse	0.75% 1/133	0.77% 1/130
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/133	0.77% 1/130
Reproductive system and breast disorders Vaginal haemorrhage	0.75% 1/133	0.00% 0/130
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.75% 1/133	0.00% 0/130
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 2/133	0.00% 0/130
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.75% 1/133	0.00% 0/130
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.75% 1/133	1.5% 2/130
Skin and subcutaneous tissue disorders Scar	0.00% 0/133	0.77% 1/130
Skin and subcutaneous tissue disorders Skin irritation	0.75% 1/133	0.00% 0/130
Social circumstances Social problem	0.75% 1/133	0.00% 0/130
Social circumstances Social stay hospitalisation	0.00% 0/133	0.77% 1/130
Surgical and medical procedures Breast reconstruction	0.75% 1/133	0.00% 0/130
Vascular disorders Deep vein thrombosis	0.75% 1/133	1.5% 2/130
Vascular disorders Hypotension	0.00% 0/133	0.77% 1/130
Vascular disorders Orthostatic hypotension	0.75% 1/133	0.00% 0/130

Other adverse events

Measure	Letrozole n=133 participants at risk 2.5 mg once daily q.d. orally for 5 years	Tam-Let n=130 participants at risk 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
Gastrointestinal disorders Constipation	8.3% 11/133	4.6% 6/130
Gastrointestinal disorders Nausea	10.5% 14/133	9.2% 12/130
General disorders Fatigue	5.3% 7/133	11.5% 15/130
General disorders Oedema peripheral	12.8% 17/133	11.5% 15/130
Injury, poisoning and procedural complications Radiation skin injury	4.5% 6/133	7.7% 10/130
Investigations Weight decreased	4.5% 6/133	5.4% 7/130
Investigations Weight increased	3.8% 5/133	5.4% 7/130
Metabolism and nutrition disorders Hypercholesterolaemia	17.3% 23/133	16.2% 21/130
Musculoskeletal and connective tissue disorders Arthralgia	33.1% 44/133	33.1% 43/130
Musculoskeletal and connective tissue disorders Back pain	10.5% 14/133	19.2% 25/130
Musculoskeletal and connective tissue disorders Bone pain	12.0% 16/133	7.7% 10/130
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.3% 11/133	6.2% 8/130
Musculoskeletal and connective tissue disorders Myalgia	3.8% 5/133	9.2% 12/130
Musculoskeletal and connective tissue disorders Osteopenia	11.3% 15/133	9.2% 12/130
Musculoskeletal and connective tissue disorders Osteoporosis	15.8% 21/133	6.2% 8/130
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 13/133	3.8% 5/130
Nervous system disorders Headache	2.3% 3/133	5.4% 7/130
Psychiatric disorders Depression	4.5% 6/133	9.2% 12/130
Psychiatric disorders Insomnia	3.8% 5/133	6.2% 8/130
Reproductive system and breast disorders Vaginal discharge	11.3% 15/133	9.2% 12/130
Reproductive system and breast disorders Vulvovaginal dryness	7.5% 10/133	3.1% 4/130
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 5/133	6.2% 8/130
Skin and subcutaneous tissue disorders Alopecia	5.3% 7/133	4.6% 6/130
Vascular disorders Hot flush	9.8% 13/133	13.8% 18/130
Vascular disorders Hypertension	18.8% 25/133	13.1% 17/130
Vascular disorders Lymphoedema	5.3% 7/133	1.5% 2/130

Additional Information

Novartis Pharmaceuticals

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 the pooled data (i.e., data from all sites) in clinical trial.
• Publication restrictions are in place

Restriction type: OTHER