CT-011 MAb in DLBCL Patients Following ASCT

• Sponsor: CureTech Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00532259
• Collaborator: (none)
• Enrollment: 72
• Locations: 27
• Arm: 1
• Duration (Months): 46
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large Cell, Diffuse; Lymphoma, Mixed Cell, Diffuse; Primary Mediastinal Large B-Cell Lymphoma	Drug: CT-011	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-011 The monoclonal antibody termed CT-011 (currently, pidilizumab).	Drug: CT-011; IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.; Other Names: Pidilizumab

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).]

   PFS (progression-free survival ) will be determined at the eligible patient populations

Secondary Outcome Measures

1. Overall Survival [within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient's age is 18 years or older, both genders.

2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.

3. The lymphoma is chemosensitive.

4. The lymphoma did not progress since pre-transplant chemotherapy.

5. ECOG performance status 0-1.

Exclusion Criteria:

1. Serious other illness.

2. Active autoimmune disease.

3. Type 1 diabetes.

4. Known immune deficiency.

5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.

6. Active bacterial, fungal, or viral infection.

7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.

8. Pregnant or nursing (positive pregnancy test).

9. Other concurrent clinical study or investigational therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moores UCSD Cancer Center	La Jolla,	California	United States	92093-0706
2	Scripps Cancer Center	San Diego	California	United States	92121
3	Northside Hospital	Atlanta,	Georgia	United States	30342
4	Emory University-Winship Cancer Institute	Atlanta	Georgia	United States	30322
5	Northwestestern Memorial Hospital	Chicago	Illinois	United States	60611-3008
6	Rush University Medical Center	Chicago	Illinois	United States	60612
7	The University of Chicago	Chicago	Illinois	United States	60637
8	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
9	University of Michigan	Ann Arbor	Michigan	United States	48109-0473
10	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
11	University of North Carolina	Chapel Hill	North Carolina	United States	27599
12	Duke University Medical Center	Durham	North Carolina	United States	27710
13	Case Western Reserve University	Cleveland	Ohio	United States	44106
14	Ohio State University	Colombus	Ohio	United States	43210
15	Temple University	Philadelphia	Pennsylvania	United States	19111-2442
16	The University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232
17	Cancer Center of the Carolinas	Greenville	South Carolina	United States	29605
18	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
19	Baylor Sammons Cancer Center	Dallas,	Texas	United States	75246
20	M.D. Anderson Cancer Center	Houston	Texas	United States	77030
21	Jaslok Hospital and Research Centre	Mumbai	Maharashtra	India	400026
22	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra	India	411004
23	Gujarat Cancer and Research Institute	Ahmedabad		India	380016
24	Rajiv Gandhi Cancer Institute and Research Centre	Delhi		India	110085
25	Rambam Medical Center	Haifa		Israel
26	Hadassah Medical Organization	Jerusalem		Israel
27	Chaim Sheba Medical Center	Tel Hashomaer, Ramat Gan		Israel

Sponsors and Collaborators

• CureTech Ltd

Investigators

• Principal Investigator: Leo I Gordon, MD, Northwestern University Feinberg School of Medicine
• Principal Investigator: Arnon Nagler, MD, Chaim Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CureTech Ltd
• ClinicalTrials.gov Identifier: NCT00532259
• Other Study ID Numbers: CT-2007-01
• First Posted: Sep 20, 2007
• Last Update Posted: Sep 12, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by CureTech Ltd: Lymphoma, Large B-Cell, Diffuse; Transformed Follicular Lymphoma; Stem cell transplantation; Relapsed; Refractory
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Pidilizumab

Study Results

Participant Flow

Recruitment Details	22 February 2008 (first patient enrolled) to 02 June 2011 (last patient completed) The study was carried out in medical centers

Arm/Group Title	CT-011 Antibody
Arm/Group Description	CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Period Title: Overall Study
STARTED	72
COMPLETED	40
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	CT-011 Antibody
Arm/Group Description	CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Overall Participants	72
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	57 79.2%
>=65 years	15 20.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.1 (13.0)
Sex: Female, Male (Count of Participants)
Female	24 33.3%
Male	48 66.7%
Region of Enrollment (participants) [Number]
United States	58 80.6%
Israel	10 13.9%
India	3 4.2%
Chile	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Description	PFS (progression-free survival ) will be determined at the eligible patient populations
Time Frame	16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).

Outcome Measure Data

Analysis Population Description

Patients who did not meet key study entry criteria were excluded from the eligible data set.

Arm/Group Title	CT-011 Antibody
Arm/Group Description	CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Measure Participants	66
Number (90% Confidence Interval) [Percent]	72

2. Secondary Outcome

Title	Overall Survival
Time Frame	within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-011
Arm/Group Description	CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Measure Participants	66
Number (90% Confidence Interval) [Percent]	85

Adverse Events

Time Frame	3 years, 3 months
Arm/Group Title	CT-011 Antibody
Arm/Group Description	CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
All Cause Mortality
	CT-011 Antibody
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CT-011 Antibody
	Affected / at Risk (%)	# Events
Total	23/72 (31.9%)
Blood and lymphatic system disorders
Neutropenia	6/72 (8.3%)	7
Thrombocytopenia	2/72 (2.8%)	4
Anemia	2/72 (2.8%)	2
Cardiac disorders
Acute myocardial infarction	1/72 (1.4%)	1
Cardiac arrest	1/72 (1.4%)	1
Gastrointestinal disorders
Abdominal pain	2/72 (2.8%)	2
Gastrointestinal haemorrhage	1/72 (1.4%)	1
General disorders
Pyrexia	1/72 (1.4%)	1
Infections and infestations
Osteomyelitis	1/72 (1.4%)	1
Clostridium difficile colitis	1/72 (1.4%)	1
Herpes zoster	1/72 (1.4%)	1
Herpes zoster disseminated	1/72 (1.4%)	1
H1n1 Influenza	1/72 (1.4%)	1
Lobar pneumonia	2/72 (2.8%)	2
Urinary tract infection	1/72 (1.4%)	1
Injury, poisoning and procedural complications
Vascular injury	1/72 (1.4%)	1
Accident	1/72 (1.4%)	1
Pelvic Fracture	1/72 (1.4%)	1
Head Injury	1/72 (1.4%)	1
Investigations
Biopsy Lymph Gland	1/72 (1.4%)	1
Laparoscopy	1/72 (1.4%)	1
Musculoskeletal and connective tissue disorders
Myositis	1/72 (1.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome	1/72 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/72 (1.4%)	1
Tachypnoea	1/72 (1.4%)	1
Chronic Obstructive Pulmonary Disease	1/72 (1.4%)	1
Productive Cough	1/72 (1.4%)	1
Acute Respiratory Distress Syndrome	1/72 (1.4%)	1
Surgical and medical procedures
Cholecystectomy	1/72 (1.4%)	1
Abdominal Hernia Repair	1/72 (1.4%)	1
Knee Arthroplasty	1/72 (1.4%)	1
Small Intestinal Resection	1/72 (1.4%)	1
Vascular disorders
Deep Vein Thrombosis	2/72 (2.8%)	2
Other (Not Including Serious) Adverse Events
	CT-011 Antibody
	Affected / at Risk (%)	# Events
Total	69/72 (95.8%)
Blood and lymphatic system disorders
Anaemia	5/69 (7.2%)	6
Leukopenia	5/72 (6.9%)	7
Lymphopenia	5/72 (6.9%)	5
Lymphadenopathy	3/72 (4.2%)	3
Neutropenia	13/72 (18.1%)	18
Idiopathic Thrombocytopenic Purpura	1/72 (1.4%)	1
Thrombocytopenia	8/72 (11.1%)	11
Cardiac disorders
Palpitations	1/72 (1.4%)	1
Mitral Valve Incompetence	1/72 (1.4%)	1
Left Ventricular Dysfunction	1/72 (1.4%)	1
Sinus Bradycardia	1/72 (1.4%)	1
Sinus Tachycardia	1/72 (1.4%)	1
Ear and labyrinth disorders
Tinnitus	1/72 (1.4%)	1
Endocrine disorders
Hypothyroidism	3/72 (4.2%)	3
Eye disorders
Blindness	1/72 (1.4%)	1
Cataract	1/72 (1.4%)	1
Conjunctivitis Allergic	1/72 (1.4%)	1
Eye Oedema	1/72 (1.4%)	1
Periorbital Oedema	2/72 (2.8%)	2
Eye Pruritus	1/72 (1.4%)	1
Vision Blurred	1/72 (1.4%)	1
Visual Impairment	1/72 (1.4%)	1
Gastrointestinal disorders
Rectal Ulcer	1/72 (1.4%)	1
Hiatus Hernia	1/72 (1.4%)	1
Diarrhoea	12/72 (16.7%)	19
Duodenal Ulcer	1/72 (1.4%)	1
Dyspepsia	3/72 (4.2%)	3
Flatulence	1/72 (1.4%)	1
Abdominal Pain	4/72 (5.6%)	4
Abdominal Pain Upper	1/72 (1.4%)	1
Gastrointestinal Pain	1/72 (1.4%)	1
Constipation	1/72 (1.4%)	1
Gastrooesophageal Reflux Disease	2/72 (2.8%)	2
Abdominal Discomfort	2/72 (2.8%)	2
Defaecation Urgency	1/72 (1.4%)	1
Nausea	8/72 (11.1%)	9
Vomiting	4/72 (5.6%)	6
Haematochezia	1/72 (1.4%)	1
Dry Mouth	2/72 (2.8%)	3
Mouth Haemorrhage	1/72 (1.4%)	1
General disorders
Asthenia	1/72 (1.4%)	1
Fatigue	18/72 (25%)	21
Pyrexia	8/72 (11.1%)	10
Chills	2/72 (2.8%)	2
Feeling Cold	1/72 (1.4%)	1
General Physical Health Deterioration	1/72 (1.4%)	1
Influenza Like Illness	1/72 (1.4%)	1
Local Swelling	1/72 (1.4%)	1
Oedema Peripheral	1/72 (1.4%)	1
Chest Discomfort	1/72 (1.4%)	1
Chest Pain	1/72 (1.4%)	2
Facial Pain	2/72 (2.8%)	2
Pain	3/72 (4.2%)	3
Hepatobiliary disorders
Cholelithiasis	2/72 (2.8%)	2
Hyperbilirubinaemia	1/72 (1.4%)	1
Hepatitis	1/72 (1.4%)	1
Immune system disorders
Seasonal Allergy	1/72 (1.4%)	1
Hypogammaglobulinaemia	1/72 (1.4%)	1
Infections and infestations
Enterocolitis Infectious	1/72 (1.4%)	1
Folliculitis	1/72 (1.4%)	1
Candidiasis	1/72 (1.4%)	1
Clostridial Infection	1/72 (1.4%)	1
Tooth Abscess	1/72 (1.4%)	1
Ear Infection	1/72 (1.4%)	2
Fungal Infection	1/72 (1.4%)	1
Gastrointestinal Fungal Infection	1/72 (1.4%)	1
Oral Fungal Infection	1/72 (1.4%)	1
Helicobacter Infection	1/72 (1.4%)	1
Herpes Zoster	4/72 (5.6%)	4
Oral Herpes	1/72 (1.4%)	1
Abscess Limb	1/72 (1.4%)	1
Influenza	3/72 (4.2%)	3
Bronchitis	4/72 (5.6%)	4
Lung Infection	1/72 (1.4%)	2
Pneumonia	1/72 (1.4%)	1
Skin Infection	1/72 (1.4%)	1
Chronic Sinusitis	1/72 (1.4%)	2
Nasopharyngitis	2/72 (2.8%)	3
Rhinitis	2/72 (2.8%)	2
Sinusitis	6/72 (8.3%)	9
Upper Respiratory Tract Infection	14/72 (19.4%)	15
Urinary Tract Infection	3/72 (4.2%)	3
Viral Rash	1/72 (1.4%)	1
Injury, poisoning and procedural complications
Procedural Nausea	1/72 (1.4%)	1
Foot Fracture	1/72 (1.4%)	1
Muscle Strain	1/72 (1.4%)	1
Anxiety Postoperative	1/72 (1.4%)	1
Fall	3/72 (4.2%)	3
Procedural Hypotension	1/72 (1.4%)	1
Procedural Pain	1/72 (1.4%)	1
Seroma	1/72 (1.4%)	1
Contusion	2/72 (2.8%)	2
Facial Bones Fracture	1/72 (1.4%)	1
Rib Fracture	1/72 (1.4%)	1
Investigations
Blood Cholesterol Increased	1/72 (1.4%)	2
Activated Partial Thromboplastin Time Prolonged	4/72 (5.6%)	7
International Normalised Ratio	1/72 (1.4%)	1
International Normalised Ratio Increased	1/72 (1.4%)	1
Electrocardiogram Abnormal	1/72 (1.4%)	1
Alanine Aminotransferase Increased	1/72 (1.4%)	1
Aspartate Aminotransferase Increased	3/72 (4.2%)	3
Hepatic Enzyme Increased	1/72 (1.4%)	1
Liver Function Test Abnormal	1/72 (1.4%)	1
Blood Phosphorus Decreased	1/72 (1.4%)	1
Blood Potassium Decreased	1/72 (1.4%)	1
Blood Sodium Decreased	1/72 (1.4%)	1
Blood Sodium Increased	1/72 (1.4%)	1
Serum Ferritin Increased	1/72 (1.4%)	1
Lymph Node Palpable	1/72 (1.4%)	1
Weight Decreased	2/72 (2.8%)	2
Weight Increased	3/72 (4.2%)	3
Blood Thyroid Stimulating Hormone Increased	1/72 (1.4%)	1
Platelet Count Decreased	5/72 (6.9%)	5
Haemoglobin Decreased	9/72 (12.5%)	9
Blood Creatinine Increased	2/72 (2.8%)	2
Blood Testosterone Decreased	1/72 (1.4%)	1
Biopsy Prostate Normal	1/72 (1.4%)	1
Blood Alkaline Phosphatase Increased	2/72 (2.8%)	3
Neutrophil Count Decreased	6/72 (8.3%)	7
White Blood Cell Count Decreased	9/72 (12.5%)	12
White Blood Cell Count Increased	1/72 (1.4%)	1
Metabolism and nutrition disorders
Decreased Appetite	5/72 (6.9%)	5
Hypocalcaemia	2/72 (2.8%)	2
Hyperuricaemia	1/72 (1.4%)	1
Hypercholesterolaemia	4/72 (5.6%)	5
Hyperglycaemia	9/72 (12.5%)	12
Hypoglycaemia	2/72 (2.8%)	2
Hypomagnesaemia	1/72 (1.4%)	2
Hypophosphataemia	2/72 (2.8%)	3
Hypokalaemia	2/72 (2.8%)	2
Hypoalbuminaemia	1/72 (1.4%)	1
Hypernatraemia	1/72 (1.4%)	1
Hyponatraemia	3/72 (4.2%)	3
Musculoskeletal and connective tissue disorders
Arthropathy	1/72 (1.4%)	1
Bone Pain	2/72 (2.8%)	2
Bursa Disorder	1/72 (1.4%)	1
Arthralgia	5/72 (6.9%)	5
Myalgia	2/72 (2.8%)	2
Muscle Spasms	1/72 (1.4%)	1
Back Pain	4/72 (5.6%)	5
Flank Pain	1/72 (1.4%)	1
Musculoskeletal Pain	4/72 (5.6%)	4
Pain In Extremity	3/72 (4.2%)	4
Mobility Decreased	1/72 (1.4%)	1
Rhabdomyolysis	1/72 (1.4%)	1
Groin Pain	2/72 (2.8%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma Recurrent	1/72 (1.4%)	1
Glioma	1/72 (1.4%)	1
Non-Hodgkin's Lymphoma	1/72 (1.4%)	1
Nervous system disorders
Haemorrhage Intracranial	1/72 (1.4%)	1
Subarachnoid Haemorrhage	1/72 (1.4%)	1
Somnolence	3/72 (4.2%)	6
Syncope	1/72 (1.4%)	1
Viith Nerve Paralysis	1/72 (1.4%)	1
Headache	6/72 (8.3%)	8
Sinus Headache	1/72 (1.4%)	1
Memory Impairment	1/72 (1.4%)	1
Dizziness	6/72 (8.3%)	6
Presyncope	2/72 (2.8%)	2
Muscle Contractions Involuntary	2/72 (2.8%)	2
Paraesthesia	2/72 (2.8%)	2
Neuropathy Peripheral	5/72 (6.9%)	5
Peripheral Sensory Neuropathy	1/72 (1.4%)	1
Neuralgia	1/72 (1.4%)	1
Restless Legs Syndrome	1/72 (1.4%)	1
Dysarthria	1/72 (1.4%)	1
Tremor	1/72 (1.4%)	1
Psychiatric disorders
Anxiety	2/72 (2.8%)	2
Depression	4/72 (5.6%)	4
Insomnia	7/72 (9.7%)	7
Libido Decreased	2/72 (2.8%)	2
Renal and urinary disorders
Dysuria	2/72 (2.8%)	2
Micturition Urgency	1/72 (1.4%)	1
Renal Failure	3/72 (4.2%)	3
Renal Cyst	1/72 (1.4%)	1
Glycosuria	1/72 (1.4%)	1
Nocturia	1/72 (1.4%)	1
Reproductive system and breast disorders
Nipple Pain	1/72 (1.4%)	1
Erectile Dysfunction	1/72 (1.4%)	1
Sexual Dysfunction	1/72 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	5/72 (6.9%)	5
Wheezing	1/72 (1.4%)	1
Hypoxia	1/72 (1.4%)	1
Cough	12/72 (16.7%)	14
Pleuritic Pain	1/72 (1.4%)	1
Nasal Congestion	4/72 (5.6%)	4
Epistaxis	1/72 (1.4%)	1
Allergic Sinusitis	1/72 (1.4%)	1
Sinus Congestion	3/72 (4.2%)	4
Pneumothorax	1/72 (1.4%)	1
Respiratory Tract Congestion	1/72 (1.4%)	1
Dry Throat	1/72 (1.4%)	1
Oropharyngeal Pain	4/72 (5.6%)	4
Rhinorrhoea	4/72 (5.6%)	4
Sneezing	1/72 (1.4%)	1
Throat Irritation	1/72 (1.4%)	1
Upper-Airway Cough Syndrome	1/72 (1.4%)	1
Skin and subcutaneous tissue disorders
Alopecia	1/72 (1.4%)	1
Hyperhidrosis	1/72 (1.4%)	1
Night Sweats	2/72 (2.8%)	2
Blister	1/72 (1.4%)	1
Dry Skin	1/72 (1.4%)	1
Hypoaesthesia Facial	1/72 (1.4%)	1
Macule	1/72 (1.4%)	1
Pain Of Skin	1/72 (1.4%)	1
Scar Pain	1/72 (1.4%)	1
Skin Lesion	1/72 (1.4%)	1
Eczema	2/72 (2.8%)	2
Rash Erythematous	3/72 (4.2%)	3
Nail Discolouration	1/72 (1.4%)	1
Onychoclasis	1/72 (1.4%)	1
Pruritus	3/72 (4.2%)	4
Rash Pruritic	2/72 (2.8%)	2
Rash	6/72 (8.3%)	7
Rash Macular	2/72 (2.8%)	2
Surgical and medical procedures
Lymphadenectomy	1/72 (1.4%)	1
Vascular disorders
Aortic Aneurysm	1/72 (1.4%)	1
Haematoma	1/72 (1.4%)	1
Deep Vein Thrombosis	1/72 (1.4%)	1
Flushing	1/72 (1.4%)	1
Hot Flush	2/72 (2.8%)	2
Hypertension	3/72 (4.2%)	3
Hypotension	7/72 (9.7%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.