Trial Outcomes & Findings for Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma (NCT NCT02208362)
NCT ID: NCT02208362
Last Updated: 2025-09-03
Results Overview
Grade 3 or higher toxicity profile for adverse events probably or definitely related to CAR T cells as assessed by the NCI CTCAE version 4.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
An average of 11 months
Results posted on
2025-09-03
Participant Flow
Arm 1 was biopsy only due to concern of potentially higher toxicity rates with increased tumor burden. After no dose-limiting toxicities were observed on Arm 1, dose schedule (DS)1, this Arm was closed and participants were included in the other dose schedules in Arm 2.
Participant milestones
| Measure |
Arm 1 Dose Schedule 1
Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
4
|
10
|
3
|
3
|
5
|
4
|
8
|
3
|
8
|
11
|
|
Overall Study
COMPLETED
|
2
|
3
|
4
|
10
|
3
|
3
|
4
|
3
|
5
|
3
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1 Dose Schedule 1
Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Participant did not complete treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Participant received disallowed treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Baseline characteristics by cohort
| Measure |
Arm 1 Dose Schedule 1
n=2 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=5 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=4 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=8 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=8 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=11 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=5 Participants
|
56 years
n=7 Participants
|
55.5 years
n=5 Participants
|
44 years
n=4 Participants
|
56 years
n=21 Participants
|
49 years
n=10 Participants
|
56 years
n=115 Participants
|
59.5 years
n=24 Participants
|
53 years
n=42 Participants
|
32 years
n=42 Participants
|
49 years
n=42 Participants
|
48 years
n=42 Participants
|
49 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
51 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
55 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
5 participants
n=115 Participants
|
4 participants
n=24 Participants
|
8 participants
n=42 Participants
|
3 participants
n=42 Participants
|
8 participants
n=42 Participants
|
11 participants
n=42 Participants
|
65 participants
n=36 Participants
|
|
Histology
Grade 4 glioblastoma IDH wildtype
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
47 Participants
n=36 Participants
|
|
Histology
Grade 4 diffuse midline glioma, H3 K27-altered
|
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=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Histology
Grade 3 astrocytoma, IDH mutant
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Histology
Grade 3 oligodendroglioma, IDH-mutant and 1p/19q-codeleted
|
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=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Histology
Grade 3 supratentorial ependymoma, NEC
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Histology
Grade 4 diffuse astrocytoma, NOS
|
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=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Histology
Grade 4 astrocytoma, IDH mutant
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: An average of 11 monthsGrade 3 or higher toxicity profile for adverse events probably or definitely related to CAR T cells as assessed by the NCI CTCAE version 4.0.
Outcome measures
| Measure |
Arm 1 Dose Schedule 1
n=2 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=5 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=4 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=8 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=8 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=11 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Encephalopathy · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Encephalopathy · No
|
2 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Ataxia · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Ataxia · No
|
2 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 1 week following the last course, up to a total of 4 weeks (not including optional courses 4-6)Population: 11 total participants were deemed not eligible for dose escalation due to the following: 7 did not receive the full 3 cycles of CAR T, 1 had too much time between surgery and CAR T, 2 received disallowed treatment, and 1 did not receive their full treatment schedule.
Toxicities will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is defined as events attributable to T-cell infusion (probable or definite) with a few expected events that resolve within a specified time and occurring from the time of initial CAR T cell infusion through 1 week following the last infusion cycle (not including optional cycles) unless otherwise specified in this definition: 1. Two grade 3 toxicities at the same dose with the exception of those grade 3 toxicities listed below. 2. Any grade 3 Cytokine release syndrome (CRS) toxicity lasting more than 72 hours without intervention 3. Any grade 3 or higher allergic reaction 4. Any grade 3 or higher autoimmune reaction 5. Any grade 4 toxicity
Outcome measures
| Measure |
Arm 1 Dose Schedule 1
n=2 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=3 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=3 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=9 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=4 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=3 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=5 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=6 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=10 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between 4 and 8 weeks post 1st CAR T infusionPopulation: 7 total participants were deemed not eligible for response due to the following: 5 did not receive the full 3 cycles of CAR T, 1 received disallowed treatment, and 1 did not receive their full treatment schedule.
Counts of active response and progression determined by RANO. Participants achieving stable disease (SD), partial remission (PR), or complete remission (CR) are counted as active. RANO: Complete Response (CR): Disappearance of all enhancing disease sustained for 4 weeks, stable or improved FLAIR/T2 lesions, no new lesions, off corticosteroids and neurologically stable or improved. Partial Response (PR): At least a 50% decrease of all measurable enhancing lesions sustained for 4 weeks, no progression of non-measurable disease, stable or improved FLAIR/T2 lesions, no new lesions, corticosteroids dose stable or reduced and neurologically stable or improved. Stable Disease (SD): Does not qualify for CR, PR or PD, stable FLAIR/T2 lesions, stable or reduced corticosteroids, clinically stable Progressive Disease (PD): At least a 25% increase in enhancing lesions despite stable or increasing steroid dose, increase in FLAIR/T2 lesions, any new lesions, clinical deteriorations.
Outcome measures
| Measure |
Arm 1 Dose Schedule 1
n=2 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=3 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=4 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=3 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=5 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=7 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=11 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Active Response Determined by Response Assessment in Neuro-Oncology (RANO) Criteria
Active
|
0 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Active Response Determined by Response Assessment in Neuro-Oncology (RANO) Criteria
Progression
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From surgery to death from any cause or six months, whichever occurred firstPopulation: 8 total participants were deemed not eligible for survival due to the following: 5 did not receive the full 3 cycles of CAR T, 1 received disallowed treatment, 1 had too much time between surgery and CAR T, and 1 did not receive their full treatment schedule.
Participants were assessed for vital status up to 6 months post surgery.
Outcome measures
| Measure |
Arm 1 Dose Schedule 1
n=2 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=3 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 Participants
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=4 Participants
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=3 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=5 Participants
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=7 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=10 Participants
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Alive at 6 Months
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
Adverse Events
Arm 1 Dose Schedule 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Arm 2 Dose Schedule 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm 2 Dose Schedule 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm 2 Dose Schedule 3
Serious events: 2 serious events
Other events: 10 other events
Deaths: 10 deaths
Arm 3 Dose Schedule 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm 3 Dose Schedule 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm 3 Dose Schedule 3
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Arm 4 Dose Schedule 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Arm 4 Dose Schedule 2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 7 deaths
Arm 5 Dose Schedule 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm 5 Dose Schedule 2
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Arm 5 Dose Schedule 3
Serious events: 5 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Arm 1 Dose Schedule 1
n=2 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=4 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=5 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=4 participants at risk
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=8 participants at risk
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=8 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=11 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
Death NOS
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
Fever
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
tumor progression and cerebritis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
L hemipheric subdural hydroma/hematoma
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
Other adverse events
| Measure |
Arm 1 Dose Schedule 1
n=2 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 1
n=4 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 2
n=4 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 2 Dose Schedule 3
n=10 participants at risk
CAR Tcm cells Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 1
n=3 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 2
n=3 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 3 Dose Schedule 3
n=5 participants at risk
CAR Tcm cells intraventricular \[ICV\]
Dose schedule 3
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 1
n=4 participants at risk
CAR Tcm cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 4 Dose Schedule 2
n=8 participants at risk
CAR Tcm cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tcm cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 1
n=3 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 1
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 2
n=8 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule 2
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
Arm 5 Dose Schedule 3
n=11 participants at risk
CAR Tn/mem cells ICTb/r and ICV
Dose schedule3
Patients receive IL13Ra2-CAR/CD19t+ Tn/mem cells via intratumoral or intracavitary catheter and intraventricular catheter weekly for 3 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
80.0%
4/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
62.5%
5/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
75.0%
6/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Sinus bradycardia
|
100.0%
2/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
54.5%
6/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
70.0%
7/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
62.5%
5/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
feeling of fullness in L ear
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
R ear feeling plugged after hyperbaric O2 tx. otitis media
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
ear pressure
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
ear congestion due to URI
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
"cloudiness" of vision, noted in OT only once
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
frequent blinking, a long term issue
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
visual disturbance
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
visual difficulty (not blurriness)
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
eye pressure
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
vision change
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
double vision
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
eyelid swelling
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
vision impairment, L peripheral
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
L visual peripheral field cut
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
36.4%
4/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
mild chewing difficulty
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
canker sore
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Cold Sore
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
food poisoning
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
62.5%
5/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
63.6%
7/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Chills
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
70.0%
7/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
General disorders
Edema face
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
Facial pain
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
Fatigue
|
100.0%
2/2 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
90.0%
9/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
80.0%
4/5 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
100.0%
8/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
87.5%
7/8 • While on study, an average of 11 months
|
90.9%
10/11 • While on study, an average of 11 months
|
|
General disorders
Fever
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
45.5%
5/11 • While on study, an average of 11 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
General disorders
diaphoresis
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
profuse sweating only on L side
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
occ chest tightness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
feeling cold
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
night sweats
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
sweating
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
drowsiness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
diaphoresis during hypoglycemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
bodyaches
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
cold intolerance
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
edema generalized (fluid retention)
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Irritability
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Malaise
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
36.4%
4/11 • While on study, an average of 11 months
|
|
General disorders
Pain
|
100.0%
2/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Edema limbs
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
General disorders
Edema trunk
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
General disorders
Localized edema
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
bacteremia, wound infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
ventriculitis, wound infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
40.0%
4/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
45.5%
5/11 • While on study, an average of 11 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Cholesterol high
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Creatinine increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Lipase increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
62.5%
5/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Investigations
Serum amylase increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Weight gain
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Investigations
Weight loss
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Investigations
Hemoglobin increased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
75.0%
6/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/2 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
60.0%
6/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
36.4%
4/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
75.0%
6/8 • While on study, an average of 11 months
|
90.9%
10/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
5/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
80.0%
4/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
75.0%
6/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
87.5%
7/8 • While on study, an average of 11 months
|
54.5%
6/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Metabolism and nutrition disorders
Obesity
|
50.0%
1/2 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
40.0%
4/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
pain/clicking of R jaw
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
compression fractures L spine
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
groin pain due to inguinal hernia; hernia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
inguinal hernia; hernia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
generalized body aches
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lump L temporal area
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
45.5%
5/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
36.4%
4/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Dysphasia
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
70.0%
7/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
5/5 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
87.5%
7/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
8/8 • While on study, an average of 11 months
|
81.8%
9/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
63.6%
7/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
tumor progression
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
olfactory aura
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Sensation of coldness near right ear. Per patient, present since surgery
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
emotional instability
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
emotional lability
|
50.0%
1/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
off balance
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
other not specified
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
pseudomeningocele
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
L hand twitching, a long term issue
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
drooling when eating from L side of mouth (per pt)
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
L sided hemiparesis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
decreased motor skills
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
slight balance issues
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
funny sensation on R side of mouth
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
subgaleal fluid collection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Nervous system disorders
strange sensation/aura
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
steroid taper
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
L sided numbness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
shuffling steps/leaning forward
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
R hemiparesis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
balance issues
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
altered mental status
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
illogical speech
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
facial twitching in AM
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
fog brain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
R leg paralysis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
R ptosis after botox injection
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Tremor
|
50.0%
1/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
45.5%
5/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
27.3%
3/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
72.7%
8/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Delusions
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
37.5%
3/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
50.0%
4/8 • While on study, an average of 11 months
|
36.4%
4/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Personality change
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
emotional lability
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
urinary/abdominal "pressure" due to UTI
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
urinary hesitancy
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
difficulty urinating
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
40.0%
2/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
1/2 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
62.5%
5/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
20.0%
2/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
problems with mucous and sputum
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrates, due to DVT/PE
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
chest tightness, inhaler helped
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis/coryza
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrates
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
chest congestion. Poss due to pembro
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
40.0%
4/10 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
66.7%
2/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
45.5%
5/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
50.0%
2/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
60.0%
3/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
skin erythema from suture abcess
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
wound drainage
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
erythema over Rickham
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
groin skin tightness, due to steroids
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
redness at temporal Rickham
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
blistered skin under headwrap
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
skin tear on leg
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
swelling over Rickham
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
skin tear, R frontal scalp due to scrape
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
skin ulceration R foot
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
blister on finger due to burn from hot water
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
erythema - steroid use
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
redness at Rickham
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
itching at Rickham
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
petechiae
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
erythema/redness on palms; cabozantanib
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
18.2%
2/11 • While on study, an average of 11 months
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
10.0%
1/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
9.1%
1/11 • While on study, an average of 11 months
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
75.0%
3/4 • While on study, an average of 11 months
|
100.0%
10/10 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
100.0%
5/5 • While on study, an average of 11 months
|
100.0%
4/4 • While on study, an average of 11 months
|
100.0%
8/8 • While on study, an average of 11 months
|
100.0%
3/3 • While on study, an average of 11 months
|
87.5%
7/8 • While on study, an average of 11 months
|
90.9%
10/11 • While on study, an average of 11 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
33.3%
1/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
25.0%
2/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/5 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
0.00%
0/4 • While on study, an average of 11 months
|
30.0%
3/10 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
20.0%
1/5 • While on study, an average of 11 months
|
25.0%
1/4 • While on study, an average of 11 months
|
0.00%
0/8 • While on study, an average of 11 months
|
0.00%
0/3 • While on study, an average of 11 months
|
12.5%
1/8 • While on study, an average of 11 months
|
0.00%
0/11 • While on study, an average of 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place