Trial Outcomes & Findings for A Study of ZN-c5 in Subjects With Breast Cancer (NCT NCT03560531)
NCT ID: NCT03560531
Last Updated: 2024-08-09
Results Overview
CBR is defined as the number of participants who have at least 1 confirmed response of complete response (CR) or partial response (PR) (only if participant has measurable disease), or stable disease (SD) \>= 24 weeks (or non-CR/non-progressive disease (PD) \>=24 weeks for participants with non-measurable disease) prior to any evidence of progression.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
181 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-08-09
Participant Flow
Study was initiated on 30 November 2018 and completed on 22 December 2022 (last participant last visit). 29 centers in Belarus, Bosnia and Herzegovina, the Czech Republic, Hungary, Lithuania, Russia, Serbia, Ukraine, and the United States enrolled the participants.
Participant milestones
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
Participants who received ZN-c5 50 mg once daily (QD) in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
Participants who received ZN-c5 75 mg twice daily (BID) in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
3
|
3
|
6
|
15
|
3
|
10
|
75
|
10
|
5
|
18
|
2
|
12
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
3
|
3
|
6
|
15
|
3
|
10
|
75
|
10
|
5
|
18
|
2
|
12
|
3
|
Reasons for withdrawal
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
Participants who received ZN-c5 50 mg once daily (QD) in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
Participants who received ZN-c5 75 mg twice daily (BID) in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
1
|
2
|
6
|
1
|
4
|
8
|
1
|
3
|
2
|
0
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Study end per-protocol
|
1
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Early study termination by sponsor
|
9
|
0
|
0
|
4
|
8
|
2
|
5
|
64
|
7
|
2
|
16
|
2
|
6
|
2
|
Baseline Characteristics
A Study of ZN-c5 in Subjects With Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
n=10 Participants
Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
n=5 Participants
Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
n=18 Participants
Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
n=2 Participants
Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
n=12 Participants
Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
n=3 Participants
Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
105 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
76 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
75 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
180 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
74 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
165 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
109 Participants
n=24 Participants
|
|
Region of Enrollment
Europe
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
72 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set consisted of all participants who received \>=1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
CBR is defined as the number of participants who have at least 1 confirmed response of complete response (CR) or partial response (PR) (only if participant has measurable disease), or stable disease (SD) \>= 24 weeks (or non-CR/non-progressive disease (PD) \>=24 weeks for participants with non-measurable disease) prior to any evidence of progression.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) for ZN-c5 as a Monotherapy
|
7 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
Best overall response was summarized categorically based on the four RECIST categories: CR, PR, SD and PD.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
SD
|
13 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
50 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
8 weeks < SD <24 weeks
|
6 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
Non-Responders (NR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
Not Evaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
SD ≥24 weeks
|
7 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
35 Participants
|
|
Best Overall Response (BOR) for ZN-c5 as a Monotherapy
PD
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival (PFS) at 2 Months
|
87.1 percentage of participants
Interval 57.3 to 96.6
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
73.3 percentage of participants
Interval 43.6 to 89.1
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
87.5 percentage of participants
Interval 38.7 to 98.1
|
77.8 percentage of participants
Interval 66.3 to 85.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 4 are reported.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival at 4 Months
|
73.7 percentage of participants
Interval 44.1 to 89.2
|
—
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
33.3 percentage of participants
Interval 4.6 to 67.6
|
50.3 percentage of participants
Interval 22.6 to 72.8
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
62.5 percentage of participants
Interval 22.9 to 86.1
|
60.8 percentage of participants
Interval 48.5 to 71.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 6 are reported.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival at 6 Months
|
64.5 percentage of participants
Interval 33.6 to 83.8
|
—
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
33.5 percentage of participants
Interval 10.8 to 58.4
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
50.0 percentage of participants
Interval 15.2 to 77.5
|
50.3 percentage of participants
Interval 38.1 to 61.3
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 8 are reported.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival at 8 Months
|
64.5 percentage of participants
Interval 33.6 to 83.8
|
—
|
0.0 percentage of participants
The 95% confidence internal data was not determined as no participants with PFS at Month 8.
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
16.8 percentage of participants
Interval 2.7 to 41.2
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
37.5 percentage of participants
Interval 8.7 to 67.4
|
44.2 percentage of participants
Interval 32.3 to 55.5
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 10 are reported.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival at 10 Months
|
55.2 percentage of participants
Interval 25.2 to 77.5
|
—
|
0.0 percentage of participants
The 95% confidence internal data was not determined as no participants with PFS at Month 10.
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
16.8 percentage of participants
Interval 2.7 to 41.2
|
0.0 percentage of participants
The 95% confidence internal data was not determined as no participants with PFS at Month 10.
|
12.5 percentage of participants
Interval 0.7 to 42.3
|
35.9 percentage of participants
Interval 24.6 to 47.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Tumor Response-Evaluable Set includes all participants in the full analysis set with at least 1 evaluable postbaseline response assessment using RECIST 1.1. Only participants with data collected at Month 12 are reported.
PFS is defined as the time (in months) from the date of first dosing until the date of objective PD (as defined by RECIST version 1.1) or death (by any cause in the absence of progression), whichever occurs earlier. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=9 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=72 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Progression-Free Survival at 12 Months
|
27.6 percentage of participants
Interval 6.9 to 53.9
|
—
|
0.0 percentage of participants
The 95% confidence internal data was not determined as no participants with PFS at Month 12.
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
16.8 percentage of participants
Interval 2.7 to 41.2
|
0.0 percentage of participants
The 95% confidence internal data was not determined as no participants with PFS at Month 12.
|
12.5 percentage of participants
Interval 0.7 to 42.3
|
26.2 percentage of participants
Interval 15.8 to 37.8
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 2 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival (OS) at 2 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
98.7 percentage of participants
Interval 90.9 to 99.8
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 4 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival at 4 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
90.0 percentage of participants
Interval 47.3 to 98.5
|
97.3 percentage of participants
Interval 89.6 to 99.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 6 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival at 6 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
90.0 percentage of participants
Interval 47.3 to 98.5
|
97.3 percentage of participants
Interval 89.6 to 99.3
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 8 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival at 8 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
90.0 percentage of participants
Interval 47.3 to 98.5
|
94.0 percentage of participants
Interval 84.8 to 97.7
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 10 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival at 10 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
83.3 percentage of participants
Interval 27.3 to 97.5
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
90.0 percentage of participants
Interval 47.3 to 98.5
|
90.0 percentage of participants
Interval 78.8 to 95.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
OS is defined as the time from the date of enrollment to the date of death from any cause. Kaplan-Meier estimates at 12 months and their confidence intervals are calculated with the log-log transformation methodology of Kalbfleisch and Prentice.
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Monotherapy Only: Percentage of Participants With Overall Survival at 12 Months
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
83.3 percentage of participants
Interval 27.3 to 97.5
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
90.0 percentage of participants
Interval 47.3 to 98.5
|
84.2 percentage of participants
Interval 69.8 to 92.1
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set consisted of all participants who received ≥1 dose of study drug and was used in the analyses of participant characteristics and efficacy endpoints.
ORR is defined as the number of participants with measurable disease who have at least 1 confirmed response of CR or PR prior to any evidence of progression (as defined by RECIST v1.1).
Outcome measures
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 Participants
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 Participants
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 Participants
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 Participants
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 Participants
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 Participants
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 Participants
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 Participants
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) for ZN-c5 as a Monotherapy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Phase 1 (Monotherapy): ZN-c5 50 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 4 deaths
Phase 1 (Monotherapy): ZN-c5 75 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 (Monotherapy): ZN-c5 100 mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 (Monotherapy): ZN-c5 75 mg BID
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1 (Monotherapy): ZN-c5 150 mg QD
Serious events: 2 serious events
Other events: 14 other events
Deaths: 6 deaths
Phase 1 (Monotherapy): ZN-c5 150 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 (Monotherapy): ZN-c5 300 mg QD
Serious events: 2 serious events
Other events: 10 other events
Deaths: 4 deaths
Phase 2 (Monotherapy): ZN-c5 50 mg QD
Serious events: 9 serious events
Other events: 55 other events
Deaths: 8 deaths
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
Serious events: 2 serious events
Other events: 18 other events
Deaths: 2 deaths
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
Serious events: 2 serious events
Other events: 12 other events
Deaths: 4 deaths
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 participants at risk
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 participants at risk
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 participants at risk
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 participants at risk
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 participants at risk
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 participants at risk
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 participants at risk
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 participants at risk
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
n=10 participants at risk
Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
n=5 participants at risk
Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
n=18 participants at risk
Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
n=2 participants at risk
Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
n=12 participants at risk
Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
n=3 participants at risk
Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Embolism
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
Other adverse events
| Measure |
Phase 1 (Monotherapy): ZN-c5 50 mg QD
n=16 participants at risk
Participants who received ZN-c5 50 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg QD
n=3 participants at risk
Participants who received ZN-c5 75 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 100 mg QD
n=3 participants at risk
Participants who received ZN-c5 100 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 75 mg BID
n=6 participants at risk
Participants who received ZN-c5 75 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg QD
n=15 participants at risk
Participants who received ZN-c5 150 mg QD in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 150 mg BID
n=3 participants at risk
Participants who received ZN-c5 150 mg BID in Phase 1 were included in this arm.
|
Phase 1 (Monotherapy): ZN-c5 300 mg QD
n=10 participants at risk
Participants who received ZN-c5 300 mg QD in Phase 1 were included in this arm.
|
Phase 2 (Monotherapy): ZN-c5 50 mg QD
n=75 participants at risk
Participants who received ZN-c5 50 mg QD in Phase 2 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg QD + Palbociclib
n=10 participants at risk
Participants who received ZN-c5 25 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 25mg BID + Palbociclib
n=5 participants at risk
Participants who received ZN-c5 25 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg QD + Palbociclib
n=18 participants at risk
Participants who received ZN-c5 50 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 50mg BID + Palbociclib
n=2 participants at risk
Participants who received ZN-c5 50 mg BID along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 100mg QD + Palbociclib
n=12 participants at risk
Participants who received ZN-c5 100 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
Phase 1 (Combination Therapy): ZN-c5 150mg QD + Palbociclib
n=3 participants at risk
Participants who received ZN-c5 150 mg QD along with Palbociclib (IBRANCE®) in Phase 1 were included in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
GGT increased
|
18.8%
3/16 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
14.7%
11/75 • Number of events 11 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
5/75 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
5/10 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
12/18 • Number of events 12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
41.7%
5/12 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
2/16 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Endocrine disorders
Goitre
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Diplopia
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Photopsia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Uveitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Eye disorders
Visual field defect
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.3%
4/75 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
9.3%
7/75 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
4/12 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
6/15 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
4/10 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
60.0%
3/5 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
6/18 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
4/12 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Asthenia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
9.3%
7/75 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Chills
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
5/10 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
55.6%
10/18 • Number of events 10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
25.0%
3/12 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Localised oedema
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Malaise
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Medical device site erythema
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Hepatobiliary disorders
Hepatic pain
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.7%
8/75 • Number of events 8 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Device related infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Otitis media
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Breast injury
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
ALT increased
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
AST increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
9.3%
7/75 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
9.3%
7/75 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
5/10 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Blood urea increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Carbohydrate antigen 27.29 increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Carcinoembryonic antigen increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.0%
6/75 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
5/10 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
6/18 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
25.0%
3/12 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
80.0%
8/10 • Number of events 8 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
60.0%
3/5 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
77.8%
14/18 • Number of events 14 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
58.3%
7/12 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
100.0%
3/3 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
27.8%
5/18 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
4/12 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Platelet count increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Tumour marker increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Weight decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.3%
4/75 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
Weight increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
70.0%
7/10 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
60.0%
3/5 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
77.8%
14/18 • Number of events 14 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
91.7%
11/12 • Number of events 11 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.3%
4/75 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
41.7%
5/12 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
27.8%
5/18 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
25.0%
3/12 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
5/10 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.3%
4/75 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
9/18 • Number of events 9 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
4/12 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
5/75 • Number of events 5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.3%
4/75 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
26.7%
4/15 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
25.0%
3/12 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
6/18 • Number of events 6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Psychiatric disorders
Mania
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Micturition urgency
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Breast necrosis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Breast pain
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
13.3%
2/15 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
9.3%
7/75 • Number of events 7 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
2/12 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
40.0%
2/5 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
1/6 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
11.1%
2/18 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
66.7%
2/3 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
6.7%
1/15 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/18 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
2/6 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
3/15 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
30.0%
3/10 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
2.7%
2/75 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
1/5 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
22.2%
4/18 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
50.0%
1/2 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
26.7%
4/15 • Number of events 4 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
4.0%
3/75 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
33.3%
1/3 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
1.3%
1/75 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
20.0%
2/10 • Number of events 2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
16.7%
3/18 • Number of events 3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/12 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/16 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/6 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/15 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
10.0%
1/10 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/75 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/10 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/5 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
5.6%
1/18 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/2 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
8.3%
1/12 • Number of events 1 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
0.00%
0/3 • 12 months
For the safety analysis, Phase 1 Monotherapy group was combined with Phase 2 Monotherapy group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In this study, investigators can share findings only after meeting these conditions: * Study results disclosed publicly by Sponsor or completed at all sites for 2 years * Investigator informs Sponsor of publication 30 days before submission * Communication won't include Sponsor's confidential information * Investigator removes sponsor's confidential information (other than the study results) and agrees to withhold for an additional 60 days in order to obtain patent protection
- Publication restrictions are in place
Restriction type: OTHER