Trial Outcomes & Findings for Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma (NCT NCT00540644)
NCT ID: NCT00540644
Last Updated: 2016-06-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
After 6 cycles
Results posted on
2016-06-21
Participant Flow
Participant milestones
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
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 - Revlimid, Cyclophosphamide, Prednisone
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
22
|
|
Overall Study
COMPLETED
|
39
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
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 - Revlimid, Cyclophosphamide, Prednisone
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Disease Progression
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Noncomplilance
|
1
|
0
|
Baseline Characteristics
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=48 Participants
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 - Revlimid, Cyclophosphamide, Prednisone
n=22 Participants
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
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 6 cyclesPopulation: All patients receiving at least one dose of study drug and having at least one post-baseline visit
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.
Outcome measures
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=45 Participants
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 - Revlimid, Cyclophosphamide, Prednisone
n=21 Participants
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.
|
|---|---|---|
|
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
|
86.7 percentage of participants
Interval 73.2 to 95.0
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
SECONDARY outcome
Timeframe: Beginning of treatment up to 5 yearsPopulation: All patients enrolled and received treatment.
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Outcome measures
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=48 Participants
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 - Revlimid, Cyclophosphamide, Prednisone
n=22 Participants
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.
|
|---|---|---|
|
Treatment Related Adverse Events Grade 3 or Higher
|
21 participants
|
11 participants
|
SECONDARY outcome
Timeframe: baseline and after last cycle (up to 6 cycles)Population: All patients enrolled and received treatment with a baseline and post-baseline measurement.
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
Outcome measures
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=29 Participants
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 - Revlimid, Cyclophosphamide, Prednisone
n=15 Participants
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.
|
|---|---|---|
|
Quality of Life Using the FACT-G Data
Physical Well-Being Change from Baseline
|
1.57 scores on a scale
Standard Deviation 6.20
|
-2.81 scores on a scale
Standard Deviation 6.14
|
|
Quality of Life Using the FACT-G Data
Social/Family Well-Being Change from Baseline
|
-0.03 scores on a scale
Standard Deviation 5.08
|
-0.23 scores on a scale
Standard Deviation 3.53
|
|
Quality of Life Using the FACT-G Data
Emotional Well-Beling Change from Baseline
|
2.52 scores on a scale
Standard Deviation 3.95
|
0.60 scores on a scale
Standard Deviation 3.22
|
|
Quality of Life Using the FACT-G Data
Functional Well-Being Change from Baseline
|
3.38 scores on a scale
Standard Deviation 5.33
|
-1.17 scores on a scale
Standard Deviation 4.97
|
|
Quality of Life Using the FACT-G Data
FACT-G Change from Baseline
|
7.44 scores on a scale
Standard Deviation 13.07
|
-3.61 scores on a scale
Standard Deviation 10.92
|
Adverse Events
Original Study - Revlimid, Cyclophosphamide, Prednisone
Serious events: 12 serious events
Other events: 48 other events
Deaths: 0 deaths
Extension - Revlimid, Cyclophosphamide, Prednisone
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=48 participants at risk
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 - Revlimid, Cyclophosphamide, Prednisone
n=22 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
4.2%
2/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Investigations
HEMOGLOBIN
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
2.1%
1/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Nervous system disorders
SEIZURE
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Psychiatric disorders
CONFUSION
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Vascular disorders
FLU-LIKE SYNDROME
|
2.1%
1/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
Other adverse events
| Measure |
Original Study - Revlimid, Cyclophosphamide, Prednisone
n=48 participants at risk
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 - Revlimid, Cyclophosphamide, Prednisone
n=22 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Ear and labyrinth disorders
OTITIS, MIDDLE EAR (NON-INFECTIOUS)
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Eye disorders
OCULAR/VISUAL - OTHER
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
31.2%
15/48 • up to 5 years
|
40.9%
9/22 • up to 5 years
|
|
Gastrointestinal disorders
DIARRHEA
|
27.1%
13/48 • up to 5 years
|
54.5%
12/22 • up to 5 years
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
2.1%
1/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
18.8%
9/48 • up to 5 years
|
27.3%
6/22 • up to 5 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
29.2%
14/48 • up to 5 years
|
36.4%
8/22 • up to 5 years
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
10.4%
5/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Gastrointestinal disorders
PAIN - PELVIS
|
0.00%
0/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Gastrointestinal disorders
VOMITING
|
6.2%
3/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
General disorders
EDEMA: LIMB
|
29.2%
14/48 • up to 5 years
|
36.4%
8/22 • up to 5 years
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
50.0%
24/48 • up to 5 years
|
63.6%
14/22 • up to 5 years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
10.4%
5/48 • up to 5 years
|
31.8%
7/22 • up to 5 years
|
|
General disorders
PAIN - CHEST/THORAX NOS
|
8.3%
4/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
General disorders
PAIN - FACE
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
General disorders
PAIN - OTHER
|
12.5%
6/48 • up to 5 years
|
22.7%
5/22 • up to 5 years
|
|
General disorders
RIGORS/CHILLS
|
12.5%
6/48 • up to 5 years
|
18.2%
4/22 • up to 5 years
|
|
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
|
4.2%
2/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Infections and infestations
INFECTION - OTHER
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
|
6.2%
3/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Injury, poisoning and procedural complications
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
0.00%
0/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Injury, poisoning and procedural complications
BURN
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA)
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
CREATININE
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
HEARING: PATIENTS WITH/WITHOUT BASELINE AUDIOGRAM AND ENROLLED IN A MONITORING PROGRAM
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
HEMOGLOBIN
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
METABOLIC/LABORATORY - OTHER
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
14.6%
7/48 • up to 5 years
|
27.3%
6/22 • up to 5 years
|
|
Investigations
PLATELETS
|
6.2%
3/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.5%
6/48 • up to 5 years
|
27.3%
6/22 • up to 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
|
10.4%
5/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER
|
10.4%
5/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER
|
6.2%
3/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS (AVASCULAR NECROSIS)
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
39.6%
19/48 • up to 5 years
|
40.9%
9/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BONE
|
25.0%
12/48 • up to 5 years
|
31.8%
7/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
12.5%
6/48 • up to 5 years
|
22.7%
5/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - JOINT
|
29.2%
14/48 • up to 5 years
|
22.7%
5/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - MUSCLE
|
4.2%
2/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - NECK
|
4.2%
2/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Nervous system disorders
ATAXIA (INCOORDINATION)
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Nervous system disorders
DIZZINESS
|
18.8%
9/48 • up to 5 years
|
18.2%
4/22 • up to 5 years
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
27.1%
13/48 • up to 5 years
|
27.3%
6/22 • up to 5 years
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
4.2%
2/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Nervous system disorders
PAIN - SINUS
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Nervous system disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
6.2%
3/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Nervous system disorders
TASTE ALTERATION (DYSGEUSIA)
|
4.2%
2/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Nervous system disorders
TREMOR
|
14.6%
7/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Psychiatric disorders
INSOMNIA
|
37.5%
18/48 • up to 5 years
|
31.8%
7/22 • up to 5 years
|
|
Psychiatric disorders
MOOD ALTERATION - ANXIETY
|
8.3%
4/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
4.2%
2/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
0.00%
0/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
16/48 • up to 5 years
|
22.7%
5/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
20.8%
10/48 • up to 5 years
|
54.5%
12/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
0.00%
0/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
6.2%
3/48 • up to 5 years
|
0.00%
0/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - THROAT/PHARYNX/LARYNX
|
4.2%
2/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
6.2%
3/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER
|
4.2%
2/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
4.2%
2/48 • up to 5 years
|
13.6%
3/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
33.3%
16/48 • up to 5 years
|
9.1%
2/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
33.3%
16/48 • up to 5 years
|
36.4%
8/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
8.3%
4/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
SWEATING (DIAPHORESIS)
|
20.8%
10/48 • up to 5 years
|
27.3%
6/22 • up to 5 years
|
|
Vascular disorders
HYPERTENSION
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
2.1%
1/48 • up to 5 years
|
4.5%
1/22 • up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place