Trial Outcomes & Findings for Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer (NCT NCT00514046)
NCT ID: NCT00514046
Last Updated: 2020-12-22
Results Overview
The MTD is the highest dose of Vandetanib tolerated at which a participant experienced a dose limiting toxicity (DLT) during the first two cycles of drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
During Cycle 1 and Cycle 2, approximately 56 days
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
5
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
5
|
0
|
1
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
transferred to another protocol
|
2
|
1
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Getting vandetanib via the REMS program
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Disease progression on study
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
n=5 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
15.14 years
STANDARD_DEVIATION 2.07 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION 0 • n=7 Participants
|
12.52 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 0 • n=4 Participants
|
12.1 years
STANDARD_DEVIATION 0 • n=21 Participants
|
17.3 years
STANDARD_DEVIATION 0 • n=8 Participants
|
13.2 years
STANDARD_DEVIATION 0 • n=8 Participants
|
11.3 years
STANDARD_DEVIATION 0 • n=24 Participants
|
16.8 years
STANDARD_DEVIATION 0 • n=42 Participants
|
14.50 years
STANDARD_DEVIATION 2.44 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Baseline Performance Status
|
100 scores on a scale
n=5 Participants
|
80 scores on a scale
n=7 Participants
|
80 scores on a scale
n=5 Participants
|
80 scores on a scale
n=4 Participants
|
100 scores on a scale
n=21 Participants
|
90 scores on a scale
n=8 Participants
|
100 scores on a scale
n=8 Participants
|
100 scores on a scale
n=24 Participants
|
100 scores on a scale
n=42 Participants
|
100 scores on a scale
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 1
|
0 pg/mL
n=5 Participants
|
18,300 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 2
|
67,100 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 3
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
4,500 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 4
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
25,900 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 5
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
18,900 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 6
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
4,600 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 7
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
2,000 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 8
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
3,500 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 9
|
500 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 10
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
57,800 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 11
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
13,300 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 12
|
6,900 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 13
|
24,200 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 14
|
21,400 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 15
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
800 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 16
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
47.700 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Calcitonin (CTN) at Enrollment
Patient 17
|
0 pg/mL
n=5 Participants
|
0 pg/mL
n=7 Participants
|
16,064 pg/mL
n=5 Participants
|
0 pg/mL
n=4 Participants
|
0 pg/mL
n=21 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=8 Participants
|
0 pg/mL
n=24 Participants
|
0 pg/mL
n=42 Participants
|
0 pg/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 1
|
0 ng/mL
n=5 Participants
|
341.1 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 2
|
130.6 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 3
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
444.2 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 4
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
247.1 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 5
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
60.2 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 6
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
17.7 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 7
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
6.8 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 8
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
115.5 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 9
|
8.1 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 10
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
801.3 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 11
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
133.4 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 12
|
28.4 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 13
|
244.5 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 14
|
84 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 15
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
5.1 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 16
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
60 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
|
Carcinoembryonic Antigen (CEA) at Enrollment
Patient 17
|
0 ng/mL
n=5 Participants
|
0 ng/mL
n=7 Participants
|
863 ng/mL
n=5 Participants
|
0 ng/mL
n=4 Participants
|
0 ng/mL
n=21 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=8 Participants
|
0 ng/mL
n=24 Participants
|
0 ng/mL
n=42 Participants
|
0 ng/mL
n=42 Participants
|
PRIMARY outcome
Timeframe: During Cycle 1 and Cycle 2, approximately 56 daysThe MTD is the highest dose of Vandetanib tolerated at which a participant experienced a dose limiting toxicity (DLT) during the first two cycles of drug.
Outcome measures
| Measure |
All Participants
n=17 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
100 mg/m^2/day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Patients were evaluated for response after every 2 cycles x 4 (prior to cycles 1, 3, 5, 7, and 9) and then after every 4 cycles X 1 (prior to cycle 13) and then every 6 cycles (prior to cycle 19, 25, 31, etc). Response was followed for an median of 59 monPopulation: This is the analysis of all 17 patients across dosing groups. Because dosing for each patient was adjusted over time based on toxicity and often patients did not have a radiographic response until they had a number of cycles of treatment, we combined all dosing groups when calculating response rate.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive Disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
All Participants
n=17 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Percentage of Participants With an Objective Response Defined as a Complete Response (CR) or Partial Response (PR)
|
59 percentage of participants
Interval 33.0 to 82.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles x 4 (prior to cycles 1, 3, 5, 7 and 9), prior to cycle 13, and then every 6 cycles (prior to cycle 19, 25, 31, etc). Patients were followed for response for a median of 59 months.Population: Patients with CEA \<2x upper limit of normal at baseline were not evaluable for this measure.
Blood was collected from participants and measured with an Axsym Analyzer then Immulite CEA method and assessed by the following response criteria. Partial Response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progression (P) is a ≥50% increase in the CEA relative to the prior value on 2 consecutive measurements at least 4 weeks apart. The patient must have been taking vandetanib for 4 weeks prior to the first measurements and must have continued to take the drug through the time that the second measurement was drawn. Stable (S) is a \<50% increase or decrease in CEA level relative to the baseline level.
Outcome measures
| Measure |
All Participants
n=5 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response
<50% decrease/<50% increase
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response
>50% increase
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response
≥50% decrease
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With an Increase or Decrease in Carcinoembryonic Antigen (CEA) Biomarker Response
Not Evaluable (NE)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (28 days)Population: This data was only analyzed after cycle 1 and was not collected from the patient who received 150mg/m\^2 dosing during cycle 1. All other patients received 100mg/m\^2 dosing during cycle 1.
Blood was collected from participants and measured with an Chemiluminescence immunoassay. Calcitonin upper limit of normal is \<10 pg/mL. A decline in CTN is defined as a ≥50% increase (e.g. tumor growth or progression) in the CTN level after treatment in cycle 1.
Outcome measures
| Measure |
All Participants
n=16 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Calcitonin (CTN) Biomarker Response After Cycle 1
|
-59 percent change in calcitonin
Interval -84.0 to -34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Pre-dose and then 1, 2, 4, 6, 8, 10 and 24 hour post dose.Population: All 11 subjects who had PK analysis were receiving a dose of 100mg/m\^2/dose at the time that the PK analysis was done. All participants are grouped together because this data was performed during cycle 1 and was not collected for the patient who received 150mg/m\^2 during cycle 1.
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
All Participants
n=11 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve (AUC 0-24h)
|
16 mcg*h/mL
Interval 13.5 to 23.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 142 months and 8 days.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants
n=5 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0)
|
5 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to Cycle 3 (each Cycle is 28 days)Hematologic Dose-Limiting Toxicity (H-DLT) is: Neutrophil count below 1,000/μL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a single neutrophil count below 500/μL (grade 4); Platelet count below 50,000/μL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a single platelet count below 25,000/μL (grade 4); A platelet transfusion administered when platelet count is below 50,000/μL is dose limiting thrombocytopenia, unless the transfusion is being administered for perioperative coverage; Grade 3 or 4 decrease in hemoglobin that can be corrected to at least 8.0 g/dl (grade 2) by transfusion of red blood cells is not a dose-limiting toxicity. Grade 3 or 4 hemolysis is a dose-limiting toxicity if it is judged to be vandetanib-related. Non-Hematologic Dose-Limiting Toxicity is any grade 3 or higher non-hematologic toxicity, with some exceptions such as Grade 3 nausea that is controlled by symptomatic treatment with anti-emetics.
Outcome measures
| Measure |
All Participants
n=5 Participants
All participants who received Vandetanib 100mg/m\^2 and 150mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 Participants
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Dose Limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib 100 mg/m^2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
n=5 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Gastroenteritis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Obstruction, GI::Gallbladder
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Hepatobiliary disorders
Pain::Gallbladder
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Prolonged QTc interval
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
Other adverse events
| Measure |
Vandetanib: First 100 mg/m^2, Then 150 mg/m^2
n=5 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 67mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 67 mg/m\^2.
|
Vandetanib 100 mg/m^2
n=5 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 100mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 100 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 63mg, 42, 21, 42, & 21mg/m^2
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 63 mg/m\^2, then 42 mg/m\^2, then 21 mg/m\^2, then 42 mg/m\^2, followed by 21 mg/m\^2.
|
Vandetanib: First 100 mg/m^2, Then 70 mg/m^2
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 70 mg/m\^2.
|
Vandetanib: First 100mg/m^2, Then 150mg/m^2, Followed by 200mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, followed by 200 mg/m\^2.
|
Vandetanib:First 100mg/m^2, Then 150mg, 100, 150, 100, 150mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 100 mg/m\^2/day, then 150 mg/m\^2, then 100 mg/m\^2, then 150 mg/m\^2, then 100 mg/m\^2, followed by 150 mg/m\^2.
|
Vandetanib: First 150mg/m^2, Then 100mg/m^2, Followed by 150mg
n=1 participants at risk
All participants who received a starting dose of Vandetanib administered as a once daily dose, continuously (1 cycle = 28 days) at a dose of 150 mg/m\^2/day, then 100 mg/m\^2.
|
|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, Duodenitis)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, Gastroenteritis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Vascular disorders
Vascular - Other (Specify, Lt LE les c/w localized pigmented purpura (capillaritis))
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Vision-blurred vision
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Vision-photophobia
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Number of events 17 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 29 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Weight gain
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Weight loss
|
20.0%
1/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, upset stomach / no diarrhea)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
80.0%
4/5 • Number of events 30 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 17 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
60.0%
3/5 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
100.0%
5/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 13 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Immune system disorders
Allergy/Immunology
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Anorexia
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
60.0%
3/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 12 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, "Mild Fe deficiency")
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Bone: spine-scoliosis
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
1/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 22 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Cardiac General - Other (Specify, "+ grade 3/6 systolic ejection murmur")
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Cardiac General - Other (Specify ystolic Heart murmur)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Constitutional Symptoms - Other (Specify, Fever not specified, ANC unknown)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
5/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,"2 cm clavicle mass nonmobile/tender to touch")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,"Abrasion to ant. Lt flank")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify ,"Clubbing nail beds fingers & toes")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, "Foot blister")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify,"J uvenile Plantar Dermatosis")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, "Several abrasions to the lower extremities")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, "Soft/mobile nodule consistent w/ a cyst")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Bil. thumb-nail changes (splitting/color change))
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Dermatitis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Dermatitis plantar)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Dyshidrotic eczema)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Erythema GT site)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Erythema on the right side of thrach)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Follcullitis-RT upper shoulder,forearm)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Folliclitis, bug bites)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Folliculitis:chest & abdomen)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Hand & Foot syndrome:water blisters)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify Ingrown toe nail)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify ,Intermittent Granuloma tissue)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Intermittent paronychia secondary to ingrown toe nails)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Intermittent seborrheic dermatitis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Lump under chin)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, Rt great toe erythema)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
5/5 • Number of events 55 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 65 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 166 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 45 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 18 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 54 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 32 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
20.0%
1/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
80.0%
4/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Endocrine disorders
Endocrine - Other (Specify, "Cold intolerance")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Endocrine disorders
Endocrine - Other (Specify, Elevated parathyroid)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Eyelid dysfunction
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
80.0%
4/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Flatulence
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Flu-like syndrome
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
60.0%
3/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, "Healing sore on oral mucosa")
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, "Slight increase in borborygmi")
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, Borborygmi)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, Borborygmi: hyperactive bowel sounds)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
1/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Hemoglobinuria
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Anus
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Oral cavity
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Hemorrhage, GU::Kidney
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Hemorrhage, GU::Uterus
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Hemorrhage/Bleeding - Other (Specify, Quaiac test (+) x2)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Endocrine disorders
Hot flashes/flushes
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Hypertension
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Incontinence, urinary
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Oral Thrush)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Paronychia Lt foot)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Pharyngitis)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify,Pt had a "cold")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Pt treated for UTI based on + urinestix")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Rt great toe paronychia)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Seborrheic dermatitis scalp)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify,Staph aureus skin infection follicular rash)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Staphilococcus aureus abcesses + for MRSA)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify ,Tinea Pedis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Tinea circinata left hand)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, URI)
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, URI nasal congestion/clear nasal discharge)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, URI:nasal congestion)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Viral gastroenteritis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Viral illness Acute Gastroenteritis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, Warts Rt knee)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection - Other (Specify, parochyia Lt great toe)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bone (osteomyelitis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Joint
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, Hyperphosphatemia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
80.0%
4/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails)
|
20.0%
1/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Bronchus
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Dental-tooth
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Kidney
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Lung (pneumonia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Middle ear (otitis media)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Pharynx
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Skin (cellulites)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Trachea
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Ungual (nails)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Infections and infestations
Infection with unknown ANC::Vagina
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Insomnia
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Investigations
Leukocytes (total WBC)
|
60.0%
3/5 • Number of events 12 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 14 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Investigations
Lymphatics - Other (Specify ,lymphyadenopathy: cervical)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Investigations
Lymphopenia
|
20.0%
1/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
60.0%
3/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, Hyperphosphate)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, Metanephephrine)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify,Parathyroid, elevated)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, Vit D defiency)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Psychiatric disorders
Mood alteration::Agitation
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Psychiatric disorders
Mood alteration::Anxiety
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Psychiatric disorders
Mood alteration::Depression
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, "Leg length discrepancy")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, "Limited ROM Lt hip")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, "Trauma Rt hip")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, Leg cramps)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, Pectus carinatum)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 14 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Neurology - Other (Specify, Tingling/pins/needles sensation from hip down when Pt lies on Lt side)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Neuropathy: sensory
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
40.0%
2/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Ocular/Visual - Other (Specify, keratoconus)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Ocular/Visual - Other (Specify, Occasional tearing of her eyes after reading a lot)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
20.0%
1/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Pain - Other (Specify ,"Body aches")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Pain - Other (Specify, Pain in rash)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Pain - Other (Specify, Pain ingrown toenails)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Pain - Other (Specify, Shooting pain Left 4 & 5th toes)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain - Other (Specify, Throat/pharynx/larynx)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Buttock
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest wall
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pain::Chest/thorax NOS
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Ear and labyrinth disorders
Pain::External ear
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
80.0%
4/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Eye disorders
Pain::Eye
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Pain::Face
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Nervous system disorders
Pain::Head/headache
|
100.0%
5/5 • Number of events 34 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 15 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 16 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Pain::Kidney
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Blood and lymphatic system disorders
Pain::Lymph node
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain::Oral-gums
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain::Stomach
|
60.0%
3/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Gastrointestinal disorders
Pain::Throat/pharynx/larynx
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain::Tumor pain
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Reproductive system and breast disorders
Pain::Vagina
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Investigations
Platelets
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
80.0%
4/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Prolonged QTc interval
|
100.0%
5/5 • Number of events 37 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 26 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Proteinuria
|
100.0%
5/5 • Number of events 35 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 16 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, "Cold symptoms: congestion")
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, Bronchitis infection)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, Cysts)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, Nasal congestion/Clear nasal discharge")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
80.0%
4/5 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
40.0%
2/5 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
100.0%
5/5 • Number of events 11 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
80.0%
4/5 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify,"Burning on urination: dysuria")
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Rigors/chills
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, Menorrhagia)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, prolonged menstruation)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Supraventricular tachycardia
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 142 months and 8 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place