Trial Outcomes & Findings for A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer (NCT NCT03473743)
NCT ID: NCT03473743
Last Updated: 2025-11-12
Results Overview
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Up to 8 weeks
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
11
|
12
|
3
|
3
|
44
|
45
|
|
Overall Study
Treated (Treated Analysis Set)
|
4
|
3
|
11
|
12
|
3
|
3
|
43
|
44
|
|
Overall Study
COMPLETED
|
4
|
3
|
5
|
3
|
2
|
2
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
6
|
9
|
1
|
1
|
23
|
28
|
Reasons for withdrawal
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Ongoing
|
0
|
0
|
6
|
8
|
1
|
1
|
22
|
24
|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=4 Participants
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
n=11 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
n=12 Participants
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
n=43 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=44 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
4 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=48 Participants
|
13 Participants
n=18 Participants
|
41 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=8 Participants
|
31 Participants
n=48 Participants
|
31 Participants
n=18 Participants
|
82 Participants
n=15 Participants
|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 6.5 • n=10 Participants
|
66.7 years
STANDARD_DEVIATION 9.07 • n=10 Participants
|
61.3 years
STANDARD_DEVIATION 11.14 • n=20 Participants
|
63.5 years
STANDARD_DEVIATION 11.41 • n=45 Participants
|
60.3 years
STANDARD_DEVIATION 0.58 • n=44 Participants
|
69 years
STANDARD_DEVIATION 3.61 • n=8 Participants
|
71.1 years
STANDARD_DEVIATION 10.18 • n=48 Participants
|
70.2 years
STANDARD_DEVIATION 8.61 • n=18 Participants
|
68.8 years
STANDARD_DEVIATION 9.96 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=48 Participants
|
11 Participants
n=18 Participants
|
30 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
7 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=48 Participants
|
33 Participants
n=18 Participants
|
93 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=48 Participants
|
2 Participants
n=18 Participants
|
5 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
10 Participants
n=45 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=8 Participants
|
39 Participants
n=48 Participants
|
37 Participants
n=18 Participants
|
105 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=48 Participants
|
5 Participants
n=18 Participants
|
13 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=48 Participants
|
2 Participants
n=18 Participants
|
9 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=8 Participants
|
36 Participants
n=48 Participants
|
36 Participants
n=18 Participants
|
98 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=48 Participants
|
6 Participants
n=18 Participants
|
16 Participants
n=15 Participants
|
|
Region of Enrollment
BELARUS
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=48 Participants
|
6 Participants
n=18 Participants
|
10 Participants
n=15 Participants
|
|
Region of Enrollment
BELGIUM
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=18 Participants
|
5 Participants
n=15 Participants
|
|
Region of Enrollment
BRAZIL
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=48 Participants
|
4 Participants
n=18 Participants
|
12 Participants
n=15 Participants
|
|
Region of Enrollment
ITALY
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=48 Participants
|
2 Participants
n=18 Participants
|
8 Participants
n=15 Participants
|
|
Region of Enrollment
POLAND
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=48 Participants
|
8 Participants
n=18 Participants
|
21 Participants
n=15 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=48 Participants
|
2 Participants
n=18 Participants
|
8 Participants
n=15 Participants
|
|
Region of Enrollment
SPAIN
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=48 Participants
|
8 Participants
n=18 Participants
|
25 Participants
n=15 Participants
|
|
Region of Enrollment
TAIWAN
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
|
Region of Enrollment
TURKEY
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=48 Participants
|
8 Participants
n=18 Participants
|
17 Participants
n=15 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=48 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
|
Region of Enrollment
UNITED STATES
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=45 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=48 Participants
|
3 Participants
n=18 Participants
|
9 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Treated analysis set included all participants who had received at least one dose of study drug.
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Outcome measures
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=4 Participants
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
n=11 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
n=12 Participants
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
n=3 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 36 monthsPopulation: Treated analysis set included all participants who had received at least one dose of study drug.
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (\>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Outcome measures
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=43 Participants
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=44 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
|
44.2 Percentage of Participants
|
54.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 36 monthsPopulation: Treated analysis set included all participants who had received at least one dose of study drug.
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
Outcome measures
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=43 Participants
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=44 Participants
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
|
43 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 years 1 monthOutcome measures
Outcome data not reported
Adverse Events
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Serious events: 4 serious events
Other events: 11 other events
Deaths: 5 deaths
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 3 deaths
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Serious events: 22 serious events
Other events: 43 other events
Deaths: 21 deaths
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Serious events: 19 serious events
Other events: 43 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=4 participants at risk
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
n=11 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
n=12 participants at risk
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
n=43 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=44 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Maculopathy
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Serous Retinal Detachment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Mass
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Herpes Ophthalmic
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Perforation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
n=4 participants at risk
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
|
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
n=11 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
n=12 participants at risk
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
n=3 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
n=43 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
n=44 participants at risk
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Angina Pectoris
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac Failure
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Sinus Bradycardia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Sinus Tachycardia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
100.0%
3/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
37.2%
16/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
38.6%
17/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Detachment of Macular Retinal Pigment Epithelium
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Detachment of Retinal Pigment Epithelium
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Dry Eye
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
13.6%
6/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Eye Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Eyelid Oedema
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.4%
5/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Lacrimal Disorder
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Macular Detachment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Serous Retinal Detachment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Trichiasis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal Inflammation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal Ulcer
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
45.5%
5/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
32.6%
14/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
15.9%
7/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
81.8%
9/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
83.3%
10/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
48.8%
21/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
45.5%
20/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
54.5%
6/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
58.3%
7/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
37.2%
16/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
59.1%
26/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival Disorder
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
20.9%
9/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
75.0%
3/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
100.0%
3/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
27.3%
3/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
75.0%
9/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
72.1%
31/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
59.1%
26/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
58.3%
7/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
22.7%
10/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Face Oedema
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
23.3%
10/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
11/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Localised Oedema
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Pain
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
General disorders
Xerosis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatobiliary Disease
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
13.6%
6/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Fungal Skin Infection
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Lip Infection
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Nail Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Oral Herpes
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
23.3%
10/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Skin Bacterial Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Skin Candida
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Strongyloidiasis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous Abscess
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
13.6%
6/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Persistent Corneal Epithelial Defect
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
32.6%
14/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
11/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
27.3%
3/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
23.3%
10/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
8/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.4%
5/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Calcium Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.3%
7/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
22.7%
10/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
International Normalised Ratio Increased
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Lipase Increased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
14.0%
6/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
8/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.3%
7/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
8/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
27.3%
3/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
41.7%
5/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.6%
8/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
20.5%
9/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
27.3%
3/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
13.6%
6/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
72.7%
8/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
83.3%
10/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
100.0%
3/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
100.0%
3/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
83.7%
36/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
68.2%
30/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.4%
5/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
20.9%
9/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
15.9%
7/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac Myxoma
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.3%
7/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
20.5%
9/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Adjustment Disorder
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Mixed Anxiety and Depressive Disorder
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
14.0%
6/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephropathy Toxic
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal Dermatitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular Cyst
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
14.0%
6/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.4%
5/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
34.9%
15/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
38.6%
17/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichen Planus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.3%
7/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.0%
3/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.3%
4/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
13.6%
6/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail Dystrophy
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
8/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail Toxicity
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.5%
2/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
36.4%
4/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
14.0%
6/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
8/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.6%
5/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
4/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
66.7%
2/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
27.3%
3/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
4/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
25.6%
11/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
22.7%
10/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
41.7%
5/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
7.0%
3/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
11.4%
5/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
18.2%
2/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
4.7%
2/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
8.3%
1/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
33.3%
1/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
16.7%
2/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
2.3%
1/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
6.8%
3/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.00%
0/4 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
9.1%
1/11 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/12 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/3 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/43 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
0.00%
0/44 • Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months
Treated analysis set included all participants who had received at least one dose of study drug.
|
Additional Information
Executive Medical Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER