Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

• Sponsor: Attaya Suvannasankha (Other)
• Overall Status: Completed
• CT.gov ID: NCT00540644
• Collaborator: Celgene (Industry)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 82
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: lenalidomide (Revlimid®); Drug: Cyclophosphamide; Drug: Prednisone	Phase 2

Detailed Description

This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Revlimid, Cyclophosphamide, Prednisone Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Prednisone every other day orally.	Drug: lenalidomide (Revlimid®); 25 mg p.o. daily on days 1-21 of each 28 day cycle; Other Names: Revlimid® ; Drug: Cyclophosphamide; 50 mg p.o. BID daily on days 1-21 of each 28 day cycle; Drug: Prednisone; 50 mg p.o. Q.O.D.

Outcome Measures

Primary Outcome Measures

1. Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria [After 6 cycles]

   Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.

Secondary Outcome Measures

1. Treatment Related Adverse Events Grade 3 or Higher [Beginning of treatment up to 5 years]

   Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

2. Quality of Life Using the FACT-G Data [baseline and after last cycle (up to 6 cycles)]

   Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:

• Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma

PLUS one or more of the following:

• Calcium elevation (11.5 mg/dl) [42.65 mmol/l]

• Renal insufficiency (1.5 x the ULN of serum creatinine)

• Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal)

• Bone disease (lytic lesions or osteopenia)

Measurable disease is defined at least one of the following three measurements:

• Serum M-protein >=1 g/dl ( or 10 g/l)

• Urine M-protein >=200 mg/24 h

• Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal

• Measurable plasmacytoma

• NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response.

Laboratory test results within these ranges:

• Absolute neutrophil count >= 1.0 x 109/L

• Platelet count >= 50 x 10(9)/L

• Hemoglobin >= 9 gm/dl

• Serum creatinine <= 2.5mg/dL.

• Total bilirubin <=1.5 x upper limit of normal

• AST (SGOT) and ALT (SGPT) <= 3 x ULN

Exclusion Criteria:

• Known hypersensitivity to thalidomide

• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

• Patients with a solitary plasmacytoma

• Patients with uncontrolled diabetes

• Patients with ≥ Grade 3 sensory neuropathy

• History of cardiac disease, with NYHA Class II or greater

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Attaya Suvannasankha
• Celgene

Investigators

• Principal Investigator: Attaya Suvannasankha, M.D., Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Attaya Suvannasankha, Assistant Professor of Medicine, Indiana University School of Medicine
• ClinicalTrials.gov Identifier: NCT00540644
• Other Study ID Numbers: 0704-06; IUCRO-0170
• First Posted: Oct 8, 2007
• Last Update Posted: Jun 21, 2016
• Last Verified: May 1, 2016

• Keywords provided by Attaya Suvannasankha, Assistant Professor of Medicine, Indiana University School of Medicine: Multiple Myeloma; Revlimid
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Prednisone; Cyclophosphamide; Lenalidomide

Study Results

Participant Flow

Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone	Extension - Revlimid, Cyclophosphamide, Prednisone
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Period Title: Overall Study
STARTED	48	22
COMPLETED	39	13
NOT COMPLETED	9	9

Baseline Characteristics

Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone	Extension - Revlimid, Cyclophosphamide, Prednisone	Total
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Total of all reporting groups
Overall Participants	48	22	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 54.2%	17 77.3%	43 61.4%
>=65 years	22 45.8%	5 22.7%	27 38.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (10.5)	59.9 (8.0)	61.2 (9.8)
Sex: Female, Male (Count of Participants)
Female	18 37.5%	8 36.4%	26 37.1%
Male	30 62.5%	14 63.6%	44 62.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	48 100%	22 100%	70 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 4.5%	1 1.4%
Asian	1 2.1%	0 0%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 8.3%	0 0%	4 5.7%
White	43 89.6%	21 95.5%	64 91.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Description	Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
Time Frame	After 6 cycles

Outcome Measure Data

Analysis Population Description

All patients receiving at least one dose of study drug and having at least one post-baseline visit

Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone	Extension - Revlimid, Cyclophosphamide, Prednisone
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Measure Participants	45	21
Number (95% Confidence Interval) [percentage of participants]	86.7 180.6%	71.4 324.5%

2. Secondary Outcome

Title	Treatment Related Adverse Events Grade 3 or Higher
Description	Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Time Frame	Beginning of treatment up to 5 years

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment.

Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone	Extension - Revlimid, Cyclophosphamide, Prednisone
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Measure Participants	48	22
Number [participants]	21 43.8%	11 50%

3. Secondary Outcome

Title	Quality of Life Using the FACT-G Data
Description	Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome
Time Frame	baseline and after last cycle (up to 6 cycles)

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment with a baseline and post-baseline measurement.

Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone	Extension - Revlimid, Cyclophosphamide, Prednisone
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.	Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
Measure Participants	29	15
Physical Well-Being Change from Baseline	1.57 (6.20)	-2.81 (6.14)
Social/Family Well-Being Change from Baseline	-0.03 (5.08)	-0.23 (3.53)
Emotional Well-Beling Change from Baseline	2.52 (3.95)	0.60 (3.22)
Functional Well-Being Change from Baseline	3.38 (5.33)	-1.17 (4.97)
FACT-G Change from Baseline	7.44 (13.07)	-3.61 (10.92)

Adverse Events

Time Frame	up to 5 years
Arm/Group Title	Original Study - Revlimid, Cyclophosphamide, Prednisone		Extension - Revlimid, Cyclophosphamide, Prednisone
Arm/Group Description	Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.		Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
All Cause Mortality
	Original Study - Revlimid, Cyclophosphamide, Prednisone		Extension - Revlimid, Cyclophosphamide, Prednisone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Original Study - Revlimid, Cyclophosphamide, Prednisone		Extension - Revlimid, Cyclophosphamide, Prednisone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/48 (25%)		5/22 (22.7%)
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE	2/48 (4.2%)		1/22 (4.5%)
Cardiac disorders
CARDIAC GENERAL - OTHER	1/48 (2.1%)		0/22 (0%)
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	2/48 (4.2%)		0/22 (0%)
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	1/48 (2.1%)		1/22 (4.5%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)	1/48 (2.1%)		0/22 (0%)
Investigations
HEMOGLOBIN	0/48 (0%)		1/22 (4.5%)
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	1/48 (2.1%)		1/22 (4.5%)
Musculoskeletal and connective tissue disorders
PAIN - BACK	1/48 (2.1%)		2/22 (9.1%)
PAIN - EXTREMITY-LIMB	1/48 (2.1%)		0/22 (0%)
Nervous system disorders
SEIZURE	1/48 (2.1%)		0/22 (0%)
Psychiatric disorders
CONFUSION	1/48 (2.1%)		1/22 (4.5%)
Renal and urinary disorders
RENAL FAILURE	2/48 (4.2%)		1/22 (4.5%)
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER	1/48 (2.1%)		0/22 (0%)
Vascular disorders
FLU-LIKE SYNDROME	1/48 (2.1%)		0/22 (0%)
HYPOTENSION	0/48 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Original Study - Revlimid, Cyclophosphamide, Prednisone		Extension - Revlimid, Cyclophosphamide, Prednisone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/48 (100%)		22/22 (100%)
Cardiac disorders
PALPITATIONS	2/48 (4.2%)		1/22 (4.5%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA	0/48 (0%)		1/22 (4.5%)
Ear and labyrinth disorders
AUDITORY/EAR - OTHER	0/48 (0%)		1/22 (4.5%)
OTITIS, MIDDLE EAR (NON-INFECTIOUS)	0/48 (0%)		1/22 (4.5%)
Eye disorders
OCULAR/VISUAL - OTHER	0/48 (0%)		1/22 (4.5%)
Gastrointestinal disorders
CONSTIPATION	15/48 (31.3%)		9/22 (40.9%)
DIARRHEA	13/48 (27.1%)		12/22 (54.5%)
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)	1/48 (2.1%)		1/22 (4.5%)
DYSPHAGIA (DIFFICULTY SWALLOWING)	1/48 (2.1%)		1/22 (4.5%)
GASTROINTESTINAL - OTHER	1/48 (2.1%)		3/22 (13.6%)
HEARTBURN/DYSPEPSIA	9/48 (18.8%)		6/22 (27.3%)
HEMORRHOIDS	0/48 (0%)		2/22 (9.1%)
NAUSEA	14/48 (29.2%)		8/22 (36.4%)
PAIN - ABDOMEN NOS	5/48 (10.4%)		3/22 (13.6%)
PAIN - PELVIS	0/48 (0%)		2/22 (9.1%)
VOMITING	3/48 (6.3%)		2/22 (9.1%)
General disorders
EDEMA: LIMB	14/48 (29.2%)		8/22 (36.4%)
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	24/48 (50%)		14/22 (63.6%)
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	5/48 (10.4%)		7/22 (31.8%)
PAIN - CHEST/THORAX NOS	4/48 (8.3%)		2/22 (9.1%)
PAIN - FACE	0/48 (0%)		1/22 (4.5%)
PAIN - OTHER	6/48 (12.5%)		5/22 (22.7%)
RIGORS/CHILLS	6/48 (12.5%)		4/22 (18.2%)
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	2/48 (4.2%)		3/22 (13.6%)
INFECTION - OTHER	1/48 (2.1%)		1/22 (4.5%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)	1/48 (2.1%)		1/22 (4.5%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH	1/48 (2.1%)		1/22 (4.5%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)	2/48 (4.2%)		1/22 (4.5%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS	3/48 (6.3%)		2/22 (9.1%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS	1/48 (2.1%)		1/22 (4.5%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	0/48 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)	0/48 (0%)		2/22 (9.1%)
BURN	0/48 (0%)		1/22 (4.5%)
FRACTURE	0/48 (0%)		1/22 (4.5%)
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA)	0/48 (0%)		1/22 (4.5%)
CREATININE	0/48 (0%)		1/22 (4.5%)
HEARING: PATIENTS WITH/WITHOUT BASELINE AUDIOGRAM AND ENROLLED IN A MONITORING PROGRAM	0/48 (0%)		1/22 (4.5%)
HEMOGLOBIN	2/48 (4.2%)		1/22 (4.5%)
METABOLIC/LABORATORY - OTHER	1/48 (2.1%)		1/22 (4.5%)
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	7/48 (14.6%)		6/22 (27.3%)
PLATELETS	3/48 (6.3%)		0/22 (0%)
Metabolism and nutrition disorders
ANOREXIA	6/48 (12.5%)		6/22 (27.3%)
DEHYDRATION	2/48 (4.2%)		1/22 (4.5%)
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	1/48 (2.1%)		1/22 (4.5%)
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR	1/48 (2.1%)		1/22 (4.5%)
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER	5/48 (10.4%)		1/22 (4.5%)
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER	5/48 (10.4%)		1/22 (4.5%)
MUSCULOSKELETAL/SOFT TISSUE - OTHER	3/48 (6.3%)		3/22 (13.6%)
OSTEONECROSIS (AVASCULAR NECROSIS)	0/48 (0%)		1/22 (4.5%)
PAIN - BACK	19/48 (39.6%)		9/22 (40.9%)
PAIN - BONE	12/48 (25%)		7/22 (31.8%)
PAIN - EXTREMITY-LIMB	6/48 (12.5%)		5/22 (22.7%)
PAIN - JOINT	14/48 (29.2%)		5/22 (22.7%)
PAIN - MUSCLE	2/48 (4.2%)		3/22 (13.6%)
PAIN - NECK	2/48 (4.2%)		2/22 (9.1%)
Nervous system disorders
ATAXIA (INCOORDINATION)	0/48 (0%)		1/22 (4.5%)
DIZZINESS	9/48 (18.8%)		4/22 (18.2%)
NEUROPATHY: SENSORY	13/48 (27.1%)		6/22 (27.3%)
PAIN - HEAD/HEADACHE	2/48 (4.2%)		2/22 (9.1%)
PAIN - SINUS	0/48 (0%)		1/22 (4.5%)
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS	0/48 (0%)		1/22 (4.5%)
SYNCOPE (FAINTING)	3/48 (6.3%)		1/22 (4.5%)
TASTE ALTERATION (DYSGEUSIA)	2/48 (4.2%)		2/22 (9.1%)
TREMOR	7/48 (14.6%)		3/22 (13.6%)
Psychiatric disorders
INSOMNIA	18/48 (37.5%)		7/22 (31.8%)
MOOD ALTERATION - ANXIETY	4/48 (8.3%)		2/22 (9.1%)
MOOD ALTERATION - DEPRESSION	2/48 (4.2%)		2/22 (9.1%)
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER	0/48 (0%)		2/22 (9.1%)
URINARY FREQUENCY/URGENCY	2/48 (4.2%)		1/22 (4.5%)
Reproductive system and breast disorders
VAGINAL DRYNESS	0/48 (0%)		1/22 (4.5%)
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)	2/48 (4.2%)		1/22 (4.5%)
COUGH	16/48 (33.3%)		5/22 (22.7%)
DYSPNEA (SHORTNESS OF BREATH)	10/48 (20.8%)		12/22 (54.5%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	0/48 (0%)		1/22 (4.5%)
NASAL CAVITY/PARANASAL SINUS REACTIONS	3/48 (6.3%)		0/22 (0%)
PAIN - THROAT/PHARYNX/LARYNX	2/48 (4.2%)		1/22 (4.5%)
PULMONARY/UPPER RESPIRATORY - OTHER	3/48 (6.3%)		3/22 (13.6%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER	2/48 (4.2%)		2/22 (9.1%)
DRY SKIN	2/48 (4.2%)		3/22 (13.6%)
PRURITUS/ITCHING	16/48 (33.3%)		2/22 (9.1%)
RASH/DESQUAMATION	16/48 (33.3%)		8/22 (36.4%)
RASH: ACNE/ACNEIFORM	4/48 (8.3%)		1/22 (4.5%)
SWEATING (DIAPHORESIS)	10/48 (20.8%)		6/22 (27.3%)
Vascular disorders
HYPERTENSION	1/48 (2.1%)		1/22 (4.5%)
THROMBOSIS/THROMBUS/EMBOLISM	1/48 (2.1%)		1/22 (4.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.