Trial Outcomes & Findings for REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (NCT NCT03435640)
NCT ID: NCT03435640
Last Updated: 2023-03-08
Results Overview
DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).
Results posted on
2023-03-08
Participant Flow
Participant milestones
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab IV (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
4
|
4
|
4
|
3
|
8
|
14
|
14
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
1
|
4
|
4
|
1
|
3
|
8
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
0
|
0
|
3
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.
The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab IV (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
0
|
0
|
3
|
0
|
0
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
n=3 Participants
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
n=3 Participants
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=8 Participants
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=14 Participants
Cohort A explored same-day administration of NKTR-262 at the RP2D (3.84 mg) and bempegaldesleukin (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
n=14 Participants
Cohort B explored same-day administration of NKTR-262 at the RP2D (3.84 mg) and bempegaldesleukin (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Age, Continuous
|
66.0 years
n=5 Participants
|
53.0 years
n=7 Participants
|
51.5 years
n=5 Participants
|
56.3 years
n=4 Participants
|
57.0 years
n=21 Participants
|
68.0 years
n=8 Participants
|
55.3 years
n=8 Participants
|
59.0 years
n=24 Participants
|
49.0 years
n=42 Participants
|
57.7 years
n=42 Participants
|
60.3 years
n=42 Participants
|
57.4 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
60 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
59 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
4 participants
n=8 Participants
|
3 participants
n=24 Participants
|
8 participants
n=42 Participants
|
14 participants
n=42 Participants
|
14 participants
n=42 Participants
|
64 participants
n=42 Participants
|
|
ECOG Performance Status
ECOG 0
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
ECOG Performance Status
ECOG 1
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
Outcome measures
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
n=3 Participants
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
n=3 Participants
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 Participants
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 Participants
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=7 Participants
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=11 Participants
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
n=13 Participants
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.Population: safety population
Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR).
Outcome measures
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
n=14 Participants
Phase 1 (dose escalation) Cohort 1 Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
n=14 Participants
Phase 1 (dose escalation) Cohort 2 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 3 Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 4 Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 5 Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 6 Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 7 Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 8 Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Phase 1 (dose escalation) Cohort 9 Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day.The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)
|
0 percentage of participants
Interval 0.0 to 23.2
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 5 deaths
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 9 deaths
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Serious events: 5 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=8 participants at risk
Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=14 participants at risk
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
n=14 participants at risk
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Malaise
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Amylase increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
Other adverse events
| Measure |
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.03 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3). The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) (administered staggered \[Day 3\] in Cycles 2-3).The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.06 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 0.12 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.24 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.48 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)
n=4 participants at risk
Patients received NKTR-262 intratumorally at 0.96 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)
n=3 participants at risk
Patients received NKTR-262 intratumorally at 1.92 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=8 participants at risk
Patients received NKTR-262 intratumorally at 3.84 mg (in Cycles 1 through 3) plus bempegaldesleukin IV at 0.006 mg/kg (starting in Cycle 2) every 3 weeks (q3w) administered on the same day. The number of patients to be enrolled per cohort was dependent the on the 3+3 study design and continued until RP2D was determined.
|
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)
n=14 participants at risk
Cohort A explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w.
|
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
n=14 participants at risk
Cohort B explored same-day administration of NKTR-262 intratumorally at the RP2D (3.84 mg) and bempegaldesleukin IV (0.006 mg/kg) q3w plus nivolumab (360 mg) q3w, starting in Cycle 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Fatigue
|
66.7%
2/3 • 4 years
|
100.0%
3/3 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
75.0%
3/4 • 4 years
|
50.0%
2/4 • 4 years
|
75.0%
3/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
4/8 • 4 years
|
57.1%
8/14 • 4 years
|
42.9%
6/14 • 4 years
|
|
General disorders
Influenza like illness
|
66.7%
2/3 • 4 years
|
0.00%
0/3 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
62.5%
5/8 • 4 years
|
57.1%
8/14 • 4 years
|
42.9%
6/14 • 4 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 4 years
|
66.7%
2/3 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
100.0%
3/3 • 4 years
|
25.0%
2/8 • 4 years
|
14.3%
2/14 • 4 years
|
64.3%
9/14 • 4 years
|
|
General disorders
Chills
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
75.0%
3/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
35.7%
5/14 • 4 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
50.0%
2/4 • 4 years
|
75.0%
3/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
General disorders
Injection site pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
14.3%
2/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Pain
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Face oedema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
General disorders
Malaise
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Asthenia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Localised oedema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Application site irritation
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Application site nodule
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Axillary pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Chest pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Injection site rash
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
General disorders
Swelling
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 4 years
|
100.0%
3/3 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
100.0%
3/3 • 4 years
|
62.5%
5/8 • 4 years
|
57.1%
8/14 • 4 years
|
57.1%
8/14 • 4 years
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
37.5%
3/8 • 4 years
|
50.0%
7/14 • 4 years
|
42.9%
6/14 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 4 years
|
66.7%
2/3 • 4 years
|
0.00%
0/4 • 4 years
|
66.7%
2/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
62.5%
5/8 • 4 years
|
28.6%
4/14 • 4 years
|
35.7%
5/14 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 4 years
|
66.7%
2/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
50.0%
2/4 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
14.3%
2/14 • 4 years
|
42.9%
6/14 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
75.0%
3/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
37.5%
3/8 • 4 years
|
28.6%
4/14 • 4 years
|
35.7%
5/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
28.6%
4/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
35.7%
5/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
66.7%
2/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • 4 years
|
66.7%
2/3 • 4 years
|
25.0%
1/4 • 4 years
|
66.7%
2/3 • 4 years
|
0.00%
0/4 • 4 years
|
50.0%
2/4 • 4 years
|
25.0%
1/4 • 4 years
|
66.7%
2/3 • 4 years
|
12.5%
1/8 • 4 years
|
14.3%
2/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
50.0%
2/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
35.7%
5/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
14.3%
2/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Macule
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
50.0%
4/8 • 4 years
|
42.9%
6/14 • 4 years
|
28.6%
4/14 • 4 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
75.0%
3/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
2/8 • 4 years
|
14.3%
2/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
28.6%
4/14 • 4 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
66.7%
2/3 • 4 years
|
50.0%
2/4 • 4 years
|
50.0%
2/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
28.6%
4/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
66.7%
2/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
14.3%
2/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
66.7%
2/3 • 4 years
|
25.0%
2/8 • 4 years
|
14.3%
2/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Weight decreased
|
33.3%
1/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
2/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Amylase increased
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Cortisol decreased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
Occult blood positive
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Investigations
Weight increased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
66.7%
2/3 • 4 years
|
12.5%
1/8 • 4 years
|
21.4%
3/14 • 4 years
|
28.6%
4/14 • 4 years
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Vascular disorders
Shock
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
50.0%
2/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
12.5%
1/8 • 4 years
|
21.4%
3/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
0.00%
0/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
25.0%
2/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Asthenopia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Blepharochalasis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Eye disorders
Corneal opacity
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Eye disorders
Retinal exudates
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
2/8 • 4 years
|
14.3%
2/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
14.3%
2/14 • 4 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
21.4%
3/14 • 4 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • 4 years
|
33.3%
1/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
12.5%
1/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
7.1%
1/14 • 4 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
7.1%
1/14 • 4 years
|
0.00%
0/14 • 4 years
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
25.0%
1/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/4 • 4 years
|
0.00%
0/3 • 4 years
|
0.00%
0/8 • 4 years
|
0.00%
0/14 • 4 years
|
0.00%
0/14 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER