Trial Outcomes & Findings for Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab (NCT NCT03674567)
NCT ID: NCT03674567
Last Updated: 2026-09-03
Results Overview
treatment-emergent adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
323 participants
Primary outcome timeframe
Approximately 18 weeks
Results posted on
2026-09-03
Participant Flow
Participant milestones
| Measure |
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
6
|
3
|
4
|
11
|
12
|
20
|
13
|
11
|
21
|
30
|
32
|
24
|
15
|
46
|
40
|
12
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
0
|
7
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
7
|
5
|
2
|
3
|
11
|
12
|
20
|
13
|
11
|
21
|
27
|
29
|
24
|
15
|
39
|
36
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Baseline characteristics by cohort
| Measure |
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
n=3 Participants
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
n=3 Participants
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
n=7 Participants
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
n=6 Participants
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
n=3 Participants
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
n=4 Participants
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
n=11 Participants
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
n=12 Participants
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
n=20 Participants
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
n=13 Participants
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
n=11 Participants
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
n=21 Participants
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
n=30 Participants
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
n=32 Participants
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
n=24 Participants
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
n=15 Participants
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
n=46 Participants
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
n=40 Participants
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
n=12 Participants
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
n=10 Participants
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
5 Participants
n=60 Participants
|
1 Participants
n=58 Participants
|
4 Participants
n=62 Participants
|
6 Participants
n=912 Participants
|
9 Participants
n=3 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=36 Participants
|
23 Participants
n=8 Participants
|
21 Participants
n=2 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=9 Participants
|
38 Participants
n=1 Participants
|
17 Participants
n=101 Participants
|
10 Participants
n=111 Participants
|
9 Participants
n=112 Participants
|
218 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
5 Participants
n=912 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=8 Participants
|
11 Participants
n=2 Participants
|
15 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
8 Participants
n=1 Participants
|
23 Participants
n=101 Participants
|
2 Participants
n=111 Participants
|
1 Participants
n=112 Participants
|
105 Participants
n=56 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
5 Participants
n=60 Participants
|
2 Participants
n=58 Participants
|
2 Participants
n=62 Participants
|
6 Participants
n=912 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=2 Participants
|
8 Participants
n=9 Participants
|
15 Participants
n=9 Participants
|
8 Participants
n=1 Participants
|
9 Participants
n=101 Participants
|
1 Participants
n=111 Participants
|
1 Participants
n=112 Participants
|
94 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=58 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=912 Participants
|
9 Participants
n=3 Participants
|
15 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=36 Participants
|
29 Participants
n=8 Participants
|
30 Participants
n=2 Participants
|
16 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
38 Participants
n=1 Participants
|
31 Participants
n=101 Participants
|
11 Participants
n=111 Participants
|
9 Participants
n=112 Participants
|
229 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
9 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
7 Participants
n=272 Participants
|
6 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=62 Participants
|
8 Participants
n=912 Participants
|
11 Participants
n=3 Participants
|
19 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=36 Participants
|
30 Participants
n=8 Participants
|
30 Participants
n=2 Participants
|
24 Participants
n=9 Participants
|
14 Participants
n=9 Participants
|
46 Participants
n=1 Participants
|
40 Participants
n=101 Participants
|
12 Participants
n=111 Participants
|
10 Participants
n=112 Participants
|
311 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
3 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
4 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=912 Participants
|
11 Participants
n=3 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=36 Participants
|
26 Participants
n=8 Participants
|
8 Participants
n=2 Participants
|
17 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
42 Participants
n=1 Participants
|
33 Participants
n=101 Participants
|
12 Participants
n=111 Participants
|
9 Participants
n=112 Participants
|
221 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
2 Participants
n=62 Participants
|
1 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
8 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=58 Participants
|
2 Participants
n=62 Participants
|
9 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=2 Participants
|
7 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
1 Participants
n=112 Participants
|
88 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
3 Participants
n=56 Participants
|
PRIMARY outcome
Timeframe: Approximately 18 weekstreatment-emergent adverse events
Outcome measures
| Measure |
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
n=24 Participants
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
n=3 Participants
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
n=3 Participants
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
n=7 Participants
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
n=6 Participants
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
n=3 Participants
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
n=4 Participants
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
n=11 Participants
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
n=12 Participants
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
n=20 Participants
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
n=13 Participants
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
n=11 Participants
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
n=21 Participants
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
n=30 Participants
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
n=32 Participants
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
n=15 Participants
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
n=46 Participants
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
n=40 Participants
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
n=12 Participants
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
n=10 Participants
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
Grade ≥ 3 TEAE
|
14 participants
|
0 participants
|
1 participants
|
5 participants
|
4 participants
|
2 participants
|
3 participants
|
8 participants
|
4 participants
|
11 participants
|
5 participants
|
7 participants
|
4 participants
|
19 participants
|
19 participants
|
4 participants
|
20 participants
|
19 participants
|
8 participants
|
5 participants
|
|
Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
Related Grade ≥ 3 TEAE
|
5 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
9 participants
|
6 participants
|
3 participants
|
11 participants
|
6 participants
|
5 participants
|
1 participants
|
|
Safety and Tolerability of FLX475 as a Single Agent and in Combination With Pembrolizumab Measured by the Incidence of Adverse Events, Including Dose-limiting Toxicities and Maximum Tolerated Dose
Related TEAE
|
18 participants
|
2 participants
|
3 participants
|
6 participants
|
6 participants
|
3 participants
|
2 participants
|
8 participants
|
8 participants
|
14 participants
|
10 participants
|
9 participants
|
12 participants
|
25 participants
|
23 participants
|
10 participants
|
36 participants
|
31 participants
|
7 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Through study completion (approximately 2 years)Population: objective response rate
Summary of Best Overall Response
Outcome measures
| Measure |
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
n=23 Participants
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
n=3 Participants
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
n=3 Participants
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
n=6 Participants
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
n=6 Participants
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
n=3 Participants
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
n=4 Participants
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
n=11 Participants
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
n=12 Participants
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
n=20 Participants
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
n=13 Participants
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
n=10 Participants
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
n=20 Participants
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
n=30 Participants
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
n=32 Participants
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
n=15 Participants
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
n=45 Participants
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
n=39 Participants
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
n=12 Participants
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
n=10 Participants
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Partial response by RECIST 1.1/iRECIST or Lugano
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
1 Participants
|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Stable disease by RECIST 1.1/iRECIST or Lugano
|
9 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
13 Participants
|
14 Participants
|
2 Participants
|
3 Participants
|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
PD by RECIST 1.1/iRECIST or Lugano
|
11 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
13 Participants
|
7 Participants
|
6 Participants
|
14 Participants
|
15 Participants
|
11 Participants
|
12 Participants
|
22 Participants
|
10 Participants
|
7 Participants
|
4 Participants
|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Inevaluable by RECIST 1.1/iRECIST or Lugano
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Subjects have missing tumor response assessment, therefore were not counted in the summary
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Overall Response Rate in Subjects Treated With FLX475 as a Single Agent and in Combination With Pembrolizumab
Complete response by RECIST 1.1/iRECIST or Lugano
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
Serious events: 1 serious events
Other events: 8 other events
Deaths: 2 deaths
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 4 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 2 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
Serious events: 3 serious events
Other events: 36 other events
Deaths: 3 deaths
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
Serious events: 2 serious events
Other events: 31 other events
Deaths: 2 deaths
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
n=3 participants at risk
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
n=3 participants at risk
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
n=7 participants at risk
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
n=6 participants at risk
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
n=3 participants at risk
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
n=4 participants at risk
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
n=11 participants at risk
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
n=12 participants at risk
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
n=20 participants at risk
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
n=13 participants at risk
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
n=11 participants at risk
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
n=21 participants at risk
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
n=30 participants at risk
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
n=32 participants at risk
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
n=24 participants at risk
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
n=15 participants at risk
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
n=46 participants at risk
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
n=40 participants at risk
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
n=12 participants at risk
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
n=10 participants at risk
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
10.0%
3/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
Other adverse events
| Measure |
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 25 mg
n=3 participants at risk
Tivumecirnon Monotherapy 25 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 50 mg
n=3 participants at risk
Tivumecirnon Monotherapy 50 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 75 mg
n=7 participants at risk
Tivumecirnon Monotherapy 75 mg
|
Part 1 (Dose Escalation) Tivumecirnon Monotherapy 100 mg
n=6 participants at risk
Tivumecirnon Monotherapy 100 mg
|
Part 1 (Dose Escalation) Tivumecirnon 50 mg + Pembrolizumab
n=3 participants at risk
Tivumecirnon 50 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 75 mg + Pembrolizumab
n=4 participants at risk
Tivumecirnon 75 mg + Pembrolizumab
|
Part 1 (Dose Escalation) Tivumecirnon 100 mg + Pembrolizumab
n=11 participants at risk
Tivumecirnon 100 mg + Pembrolizumab
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M1)
n=12 participants at risk
Tivumecirnon Monotherapy (M1 = EBV+ nasopharyngeal cancer)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M2)
n=20 participants at risk
Tivumecirnon Monotherapy (M2 = EBV+ Hodgkin or non-Hodgkin lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M3)
n=13 participants at risk
Tivumecirnon Monotherapy (M3 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M4)
n=11 participants at risk
Tivumecirnon Monotherapy (M4 = recurrent or metastatic cervical squamous cell carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon Monotherapy (M5)
n=21 participants at risk
Tivumecirnon Monotherapy (M5 = EBV-negative lymphoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C1)
n=30 participants at risk
Tivumecirnon + Pembrolizumab (C1 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C2)
n=32 participants at risk
Tivumecirnon + Pembrolizumab (C2 = recurrent or metastatic HNSCC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C3)
n=24 participants at risk
Tivumecirnon + Pembrolizumab (C3 = Stage IIIB/IV NSCLC (prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C4)
n=15 participants at risk
Tivumecirnon + Pembrolizumab (C4 = metastatic TNBC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C8)
n=46 participants at risk
Tivumecirnon + Pembrolizumab (C8 = EBV+ nasopharyngeal carcinoma)
|
Part 2 (Cohort Expansion) Tivumecirnon + Pembrolizumab (C9)
n=40 participants at risk
Tivumecirnon + Pembrolizumab (C9 = Stage IIIB/IV NSCLC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C10)
n=12 participants at risk
Lead-in Tivumecirnon + Pembrolizumab (C10 = EBV+ nasopharyngeal carcinoma (no prior anti-PD-1 or anti-PD-L1 therapy))
|
Part 2 (Cohort Expansion) Lead-in Tivumecirnon + Pembrolizumab (C11)
n=10 participants at risk
Lead-in Tivumecirnon + Pembrolizumab (C11 = recurrent or metastatic HNSCC (no prior anti-PD-1 or anti-PD-L1 therapy))
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
28.6%
2/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
9.4%
3/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
7.5%
3/40 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
20.0%
2/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
25.0%
1/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
4.3%
2/46 • approximately 2 years
|
5.0%
2/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
25.0%
1/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
18.2%
2/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
2/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
33.3%
2/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
4.8%
1/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
15.6%
5/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
26.7%
4/15 • approximately 2 years
|
4.3%
2/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
6.5%
3/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
10.0%
4/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
25.0%
1/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
28.6%
2/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
10.0%
3/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
6.5%
3/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
13.3%
2/15 • approximately 2 years
|
13.0%
6/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
25.0%
1/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • approximately 2 years
|
66.7%
2/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
13.3%
2/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
5.0%
2/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
66.7%
2/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
9.4%
3/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
4.3%
2/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
20.0%
2/10 • approximately 2 years
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
10.0%
3/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
5.0%
2/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Amylase increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
4.8%
1/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
5.0%
1/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
4.8%
1/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
5.0%
1/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
13.3%
4/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
13.0%
6/46 • approximately 2 years
|
15.0%
6/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
30.0%
3/10 • approximately 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
9.4%
3/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
8.7%
4/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Malaise
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
9.4%
3/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
13.3%
2/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
9.4%
3/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Hyperhidrosis
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
57.1%
4/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
36.4%
4/11 • approximately 2 years
|
33.3%
4/12 • approximately 2 years
|
35.0%
7/20 • approximately 2 years
|
53.8%
7/13 • approximately 2 years
|
36.4%
4/11 • approximately 2 years
|
38.1%
8/21 • approximately 2 years
|
33.3%
10/30 • approximately 2 years
|
43.8%
14/32 • approximately 2 years
|
41.7%
10/24 • approximately 2 years
|
33.3%
5/15 • approximately 2 years
|
30.4%
14/46 • approximately 2 years
|
50.0%
20/40 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
50.0%
5/10 • approximately 2 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
3.1%
1/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
6.5%
3/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Investigations
Weight decreased
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
28.6%
2/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
2/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
18.2%
2/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
12.5%
4/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
19.6%
9/46 • approximately 2 years
|
17.5%
7/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
50.0%
2/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
25.0%
5/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
9.5%
2/21 • approximately 2 years
|
10.0%
3/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
8.3%
2/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
15.2%
7/46 • approximately 2 years
|
30.0%
12/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
General disorders
Chills
|
0.00%
0/3 • approximately 2 years
|
66.7%
2/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
16.7%
1/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Asthenia
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Decreased appetite
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
9.1%
1/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
7.7%
1/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
6.7%
2/30 • approximately 2 years
|
6.2%
2/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
4.3%
2/46 • approximately 2 years
|
7.5%
3/40 • approximately 2 years
|
33.3%
4/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
25.0%
1/4 • approximately 2 years
|
27.3%
3/11 • approximately 2 years
|
8.3%
1/12 • approximately 2 years
|
10.0%
2/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
4.8%
1/21 • approximately 2 years
|
16.7%
5/30 • approximately 2 years
|
15.6%
5/32 • approximately 2 years
|
4.2%
1/24 • approximately 2 years
|
13.3%
2/15 • approximately 2 years
|
13.0%
6/46 • approximately 2 years
|
2.5%
1/40 • approximately 2 years
|
41.7%
5/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • approximately 2 years
|
33.3%
1/3 • approximately 2 years
|
14.3%
1/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
18.2%
2/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
3.3%
1/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
6.7%
1/15 • approximately 2 years
|
2.2%
1/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
16.7%
2/12 • approximately 2 years
|
10.0%
1/10 • approximately 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
33.3%
1/3 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/7 • approximately 2 years
|
0.00%
0/6 • approximately 2 years
|
0.00%
0/3 • approximately 2 years
|
0.00%
0/4 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/20 • approximately 2 years
|
0.00%
0/13 • approximately 2 years
|
0.00%
0/11 • approximately 2 years
|
0.00%
0/21 • approximately 2 years
|
0.00%
0/30 • approximately 2 years
|
0.00%
0/32 • approximately 2 years
|
0.00%
0/24 • approximately 2 years
|
0.00%
0/15 • approximately 2 years
|
0.00%
0/46 • approximately 2 years
|
0.00%
0/40 • approximately 2 years
|
0.00%
0/12 • approximately 2 years
|
0.00%
0/10 • approximately 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60