Trial Outcomes & Findings for Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00401778)
NCT ID: NCT00401778
Last Updated: 2016-12-21
Results Overview
All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Day 21
Results posted on
2016-12-21
Participant Flow
All enrolled patients were recruited through the multidisciplinary thoracic oncology clinics of Emory Clinic of Emory University.
Eligible patients were enrolled concurrently on the active and control arms. Patient preference for a specific arm was entertained until the control cohort was completely filled after which all patients were competitively enrolled on the active treatment arm of the study.
Participant milestones
| Measure |
Control
No everolimus taken.
|
Everolimus 5 mg
Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Everolimus 10 mg
Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
No everolimus taken.
|
Everolimus 5 mg
n=12 Participants
Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Everolimus 10 mg
n=11 Participants
Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
58 years
n=7 Participants
|
70 years
n=5 Participants
|
64 years
n=4 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 21All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.
Outcome measures
| Measure |
Control
n=9 Participants
No everolimus taken.
|
Everolimus 5 mg
n=11 Participants
Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Everolimus 10 mg
n=10 Participants
Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|---|
|
Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.
Progressive metabolic disease (PM)
|
22 percentage of patients
|
36 percentage of patients
|
50 percentage of patients
|
|
Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.
Stable metabolic disease (SMD)
|
78 percentage of patients
|
64 percentage of patients
|
50 percentage of patients
|
PRIMARY outcome
Timeframe: 6 monthsChanges in the expression of key signaling proteins in the mTOR/phosphatidylinositol 3-kinase (PI3K) pathway were determined by immunohistochemistry using previously published protocols and manufacturers' recommendations for antigen retrieval and antibody dilution along with positive and negative controls. Two investigators assessed protein expression jointly by light microscopy. The degree of expression was assessed by intensity (0, 1+, 2+, 3+) and percentage of cell staining in line with published algorithm. A derivative score (immunoscore) ranging between 0 and 300 was calculated as the product of intensity and percent cell staining.
Outcome measures
| Measure |
Control
n=9 Participants
No everolimus taken.
|
Everolimus 5 mg
n=11 Participants
Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Everolimus 10 mg
n=10 Participants
Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|---|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
S6
|
-36.06 % change in immunoscore
Standard Deviation 100.02
|
-13.69 % change in immunoscore
Standard Deviation 144.05
|
-77.03 % change in immunoscore
Standard Deviation 16.02
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
pS6
|
-41.25 % change in immunoscore
Standard Deviation 65.62
|
-61.57 % change in immunoscore
Standard Deviation 35.8
|
-47.21 % change in immunoscore
Standard Deviation 44.96
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
pS6/S6
|
-85.75 % change in immunoscore
Standard Deviation 20.15
|
-100 % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
128.57 % change in immunoscore
Standard Deviation 219.26
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
pMTOR
|
-6.58 % change in immunoscore
Standard Deviation 138.88
|
30 % change in immunoscore
Standard Deviation 153.95
|
-63.82 % change in immunoscore
Standard Deviation 51.3
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
p4E-BP1
|
-95.37 % change in immunoscore
Standard Deviation 4.24
|
150 % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
-78.75 % change in immunoscore
Standard Deviation 14.36
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
p70s6k
|
25 % change in immunoscore
Standard Deviation 176.78
|
137.14 % change in immunoscore
Standard Deviation 442.07
|
-78.62 % change in immunoscore
Standard Deviation 22.79
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
p70s6k Cytoplasmic
|
-19.17 % change in immunoscore
Standard Deviation 73.16
|
0.56 % change in immunoscore
Standard Deviation 14.93
|
305.37 % change in immunoscore
Standard Deviation 686.3
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
p70s6k Nuclear
|
-3.33 % change in immunoscore
Standard Deviation 100.17
|
135 % change in immunoscore
Standard Deviation 49.5
|
223.43 % change in immunoscore
Standard Deviation 437.7
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
pe1f4e
|
-50 % change in immunoscore
Standard Deviation 86.6
|
2.78 % change in immunoscore
Standard Deviation 5.56
|
-27.13 % change in immunoscore
Standard Deviation 42.17
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
PAKT Nuclear
|
-33.33 % change in immunoscore
Standard Deviation 57.74
|
NA % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
0 % change in immunoscore
Standard Deviation 0
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
PAKT Cytoplasmic
|
200 % change in immunoscore
Standard Deviation 469.04
|
NA % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
-25 % change in immunoscore
Standard Deviation 50
|
|
Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).
Bim
|
-11.76 % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
NA % change in immunoscore
Standard Deviation NA
Insufficient tissue sample for testing
|
-21.76 % change in immunoscore
Standard Deviation 60.07
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Control
n=10 Participants
No everolimus taken.
|
Everolimus 5 mg
n=20 Participants
Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
|
Everolimus 10 mg
Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|---|
|
Duration of Hospital Stay Following Surgery.
|
5 days
Interval 2.0 to 15.0
|
5 days
Interval 3.0 to 43.0
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Everolimus 5 & 10 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=10 participants at risk
No everolimus taken.
|
Everolimus 5 & 10 mg
n=23 participants at risk
Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Symptomatic Progression of Lung Cancer
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
Other adverse events
| Measure |
Control
n=10 participants at risk
No everolimus taken.
|
Everolimus 5 & 10 mg
n=23 participants at risk
Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/10 • 4 weeks
|
91.3%
21/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • 4 weeks
|
43.5%
10/23 • 4 weeks
|
|
Vascular disorders
Elevated Cholesterol
|
0.00%
0/10 • 4 weeks
|
56.5%
13/23 • 4 weeks
|
|
General disorders
Fatigue
|
0.00%
0/10 • 4 weeks
|
60.9%
14/23 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
General disorders
Night Sweats
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
General disorders
Fever
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Renal and urinary disorders
Elevated Creatinine
|
0.00%
0/10 • 4 weeks
|
34.8%
8/23 • 4 weeks
|
|
General disorders
Insomnia
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
General disorders
Hoarseness
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Metabolism and nutrition disorders
Weight-loss
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 4 weeks
|
34.8%
8/23 • 4 weeks
|
|
General disorders
Nausea
|
0.00%
0/10 • 4 weeks
|
34.8%
8/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Elevated ALT
|
0.00%
0/10 • 4 weeks
|
39.1%
9/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Elevated AST
|
0.00%
0/10 • 4 weeks
|
43.5%
10/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Elevated Alkaline Phosphatase
|
0.00%
0/10 • 4 weeks
|
39.1%
9/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
0.00%
0/10 • 4 weeks
|
52.2%
12/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/10 • 4 weeks
|
43.5%
10/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/10 • 4 weeks
|
43.5%
10/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 4 weeks
|
52.2%
12/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
0.00%
0/10 • 4 weeks
|
17.4%
4/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
0.00%
0/10 • 4 weeks
|
52.2%
12/23 • 4 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty in Breathing
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
0.00%
0/10 • 4 weeks
|
65.2%
15/23 • 4 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Immune system disorders
Low Leukocytes
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Mouth Sores
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/10 • 4 weeks
|
17.4%
4/23 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • 4 weeks
|
26.1%
6/23 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Gastrointestinal disorders
Reflux
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Renal and urinary disorders
Burning with Urination
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Pain in Lower Flank
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Intermittent Discomfort in Left Leg
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Low Platelets
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Infections and infestations
MRSA Bacteremia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Malaise
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • 4 weeks
|
30.4%
7/23 • 4 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • 4 weeks
|
13.0%
3/23 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Sinusitis
|
0.00%
0/10 • 4 weeks
|
21.7%
5/23 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Nervous system disorders
Pain
|
0.00%
0/10 • 4 weeks
|
26.1%
6/23 • 4 weeks
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
General disorders
Dizziness
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
General disorders
Restlessness
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Confusion
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Loss of Energy
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Difficulty in Walking
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Loss of Balance
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Eye disorders
Conjuctivitis
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Photosensitivity
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • 4 weeks
|
8.7%
2/23 • 4 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Ear and labyrinth disorders
Ear Ache
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
|
General disorders
Cramping Feet
|
0.00%
0/10 • 4 weeks
|
4.3%
1/23 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place