Trial Outcomes & Findings for Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing (NCT NCT03109015)
NCT ID: NCT03109015
Last Updated: 2024-10-08
Results Overview
Exercise Capacity will be assessed using Cardiopulmonary Exercise Testing (CPET) to determine VO2peak. Higher VO2 peak measured in mg/ml/min indicates better cardiac function. Mean change in cardiac functions will be assessed by the difference in Relative Peak VO2 from baseline to 12 weeks in both the arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Schedule 4/2
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing
Baseline characteristics by cohort
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
68 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.27 kg/m^2
n=5 Participants
|
26.55 kg/m^2
n=7 Participants
|
30.53 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 12Exercise Capacity will be assessed using Cardiopulmonary Exercise Testing (CPET) to determine VO2peak. Higher VO2 peak measured in mg/ml/min indicates better cardiac function. Mean change in cardiac functions will be assessed by the difference in Relative Peak VO2 from baseline to 12 weeks in both the arms.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Relative VO2 Peak From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
-1.13 mL/kg/min
Standard Deviation 2
|
1.27 mL/kg/min
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in cardiac functions will be assessed by the difference in LVEF measured by 2D-Echo from baseline to 12 weeks in both the arms. Higher LVEF measured in percentage indicates better cardiac function.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Difference Between Rest Left Ventricular Ejection Fraction (LVEF) and Cardiac Function by 2-D Echocardiography (2DE) From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
1.5 percentage
Standard Deviation 4.1
|
-9.0 percentage
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: No data collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) between week 12 and baseline. A 1-RM is defined as the greatest resistance that can be moved through the full range of motion in a controlled manner. This assessment included following exercises: leg press, chest press, and row. The heaviest weight lifted while adhering to the strict technique and form will be used to score the assessment.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in One Repetition Maximum (1RM) in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Seated Row
|
7 pounds
Standard Deviation 20
|
6.67 pounds
Standard Deviation 35.2
|
|
Change in One Repetition Maximum (1RM) in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Chest Press
|
-6.5 pounds
Standard Deviation 12.7
|
-6.0 pounds
Standard Deviation 18.5
|
|
Change in One Repetition Maximum (1RM) in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Leg Press
|
52.25 pounds
Standard Deviation 83.1
|
15 pounds
Standard Deviation 105
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in upper and lower extremity maximal muscular strength as measured by the muscular endurance which is 70% of 1-RM between week 12 and baseline. Muscular Endurance of the upper and lower body will be assessed as the number of repetitions to fatigue at 70% of the 1-RM. The same exercises and methods will be used as in the 1-RM determination.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Muscular Endurance in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Seated Row
|
1.25 pounds
Standard Deviation 7.5
|
4.33 pounds
Standard Deviation 24.8
|
|
Change in Muscular Endurance in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Chest Press
|
-4.5 pounds
Standard Deviation 8.9
|
-4.0 pounds
Standard Deviation 12.5
|
|
Change in Muscular Endurance in Upper and Lower Extremity Muscular Strength From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Leg Press
|
36.5 pounds
Standard Deviation 58.9
|
10.33 pounds
Standard Deviation 73.5
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: No data collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 12The 5-repetition Chair-Stand Test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver performed on a chair. Standardized instructions are: "By the count of 3, please stand up and sit down as quickly as possible for 5 times. Place your hands on your lap, and do not use them throughout the procedure. Lean your back against the chair's backrest at the end of every repetition." Note: Timing will start when the subject's back left the backrest and will be stopped once the back touched the backrest.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Time Taken to Complete the 5-repititionChair-stand Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
-0.43 seconds
Standard Deviation 0.9
|
-2.05 seconds
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline, week 12Timed Up and Go (TUG) test assesses a person's mobility. TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Scores of 10 seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail, elderly, and disabled subjects, and greater than 20 seconds suggests that further examination is required.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Time Taken to Complete the Timed up and Go Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
-0.5 seconds
Standard Deviation 1.3
|
0 seconds
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, week 12Subjects will be instructed to cover the longest distance possible in 6 minutes under the supervision of an exercise physiologist or trained designee. The walked distance will be determined in a measured corridor between 2 cones that were placed 30 meters apart
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Distance Walked During the 6 Minute Walk Test From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
1.43 meters
Standard Deviation 13.3
|
-69.2 meters
Standard Deviation 83.1
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in PRO: FACIT-Fatigue (FACIT-F, range 0 to 52) aggregate score between week 12 and baseline. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
-2.89 score on a scale
Standard Deviation 3.8
|
-2.87 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in PRO: FKSI- 19 (FKSI-19 Range 0 to 76) aggregate score between week 12 and baseline. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy - Kidney Symptom Index - 19 (FKSI-19) Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
2.75 score on a scale
Standard Deviation 4.8
|
-1.0 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in PRO: HADS (HADS, range 0 to 21) aggregate score between week 12 and baseline. The HADS score has 2- subscales: Depression and Anxiety. Each sub-scale ranges from 0, 21. Higher scores indicate higher levels of depression and anxiety.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Survey (HADS) Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Change in Anxiety (HADS)
|
0.75 score on a scale
Standard Deviation 1.5
|
0.3 score on a scale
Standard Deviation 1.1
|
|
Change in Hospital Anxiety and Depression Survey (HADS) Score From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
Change in Depression (HADS)
|
0.0 score on a scale
Standard Deviation 2.4
|
1.3 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, week 12Mean change in PRO: Godin-Leisure questionnaire aggregate score between week 12 and baseline. This represents the activity level of a participant. There are no standard reference range for this assessment. Higher scores indicate higher physical activity.
Outcome measures
| Measure |
Schedule 4/2
n=4 Participants
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 Participants
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Change in Leisure Activity Score From the Godin-Leisure Questionnaire From Baseline to Week 12 in the 4/2 and 2/1 Sunitinib Administration Schedules
|
1.67 score on a scale
Standard Deviation 17.6
|
0.5 score on a scale
Standard Deviation 36.1
|
Adverse Events
Schedule 4/2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Schedule 2/1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Schedule 4/2
n=4 participants at risk
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 participants at risk
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
Other adverse events
| Measure |
Schedule 4/2
n=4 participants at risk
Sunitinib: Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
|
Schedule 2/1
n=3 participants at risk
Sunitinib: Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Investigations
Weight loss
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Eye disorders
Blurred vision
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
4/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
2/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Hypogeusia
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
75.0%
3/4 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
General disorders
Fatigue
|
75.0%
3/4 • 12 weeks
|
100.0%
3/3 • 12 weeks
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
General disorders
Pain
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Infections and infestations
Cellulitis, left knee
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Gout, left knee
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Nervous system disorders
Dysgeusia
|
75.0%
3/4 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
75.0%
3/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
2/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
75.0%
3/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place