Trial Outcomes & Findings for MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL) (NCT NCT04157686)
NCT ID: NCT04157686
Last Updated: 2024-08-09
Results Overview
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
957 participants
Primary outcome timeframe
Baseline to Day 720 or Study Exit
Results posted on
2024-08-09
Participant Flow
Approximately 800 participants were planned to be enrolled. A total of 957 participants were enrolled and treated, and 759 participants completed the study. There were 957 participants in the intent-to-treat (ITT) population, which were used for the efficacy of US FDA and safety analyses.
Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006(NCT03732833) (referred to as Lead-In studies). Participants from the lead-in studies, who met the eligibility criteria, were enrolled to continue receiving additional cycles of MT10109L in their respective treatment areas (Glabellar area or Lateral Canthal Lines area).
Participant milestones
| Measure |
Placebo/MT10109L Dose 1
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
118
|
116
|
108
|
128
|
123
|
253
|
|
Overall Study
COMPLETED
|
43
|
41
|
89
|
87
|
83
|
106
|
92
|
218
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
29
|
29
|
25
|
22
|
31
|
35
|
Reasons for withdrawal
| Measure |
Placebo/MT10109L Dose 1
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
3
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
8
|
6
|
6
|
3
|
7
|
9
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
10
|
12
|
20
|
12
|
11
|
18
|
24
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
1
|
0
|
3
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
COVID-19, Family Reasons etc.
|
0
|
2
|
4
|
1
|
4
|
6
|
0
|
1
|
Baseline Characteristics
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Baseline characteristics by cohort
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
Total
n=957 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
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
120 Participants
n=8 Participants
|
113 Participants
n=8 Participants
|
241 Participants
n=24 Participants
|
902 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
55 Participants
n=42 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 12.17 • n=4 Participants
|
47.1 years
STANDARD_DEVIATION 10.34 • n=21 Participants
|
47.8 years
STANDARD_DEVIATION 11.24 • n=8 Participants
|
48.5 years
STANDARD_DEVIATION 10.53 • n=8 Participants
|
47.9 years
STANDARD_DEVIATION 10.80 • n=24 Participants
|
47.7 years
STANDARD_DEVIATION 11.06 • n=42 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
103 Participants
n=8 Participants
|
227 Participants
n=24 Participants
|
826 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
131 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
85 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
118 Participants
n=8 Participants
|
230 Participants
n=24 Participants
|
872 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
123 Participants
n=8 Participants
|
119 Participants
n=8 Participants
|
241 Participants
n=24 Participants
|
915 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study.
The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Any Adverse Event (AE)
|
39 Participants
|
39 Participants
|
80 Participants
|
89 Participants
|
74 Participants
|
80 Participants
|
89 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study exitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study.
This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
|
18 Participants
|
4 Participants
|
31 Participants
|
34 Participants
|
11 Participants
|
22 Participants
|
42 Participants
|
73 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
The outcome reported here is the mean change in pulse rate from baseline to study exit.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulse Rate (Beats Per Minute)
|
3.2 beats/min
Standard Deviation 15.01
|
-2.2 beats/min
Standard Deviation 13.35
|
-1.2 beats/min
Standard Deviation 10.95
|
2.0 beats/min
Standard Deviation 12.77
|
0.6 beats/min
Standard Deviation 11.58
|
0.7 beats/min
Standard Deviation 10.97
|
3.0 beats/min
Standard Deviation 10.34
|
1.0 beats/min
Standard Deviation 8.93
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
|
1.4 mmHg
Standard Deviation 12.59
|
-1.9 mmHg
Standard Deviation 10.44
|
1.9 mmHg
Standard Deviation 14.44
|
0.6 mmHg
Standard Deviation 16.72
|
1.1 mmHg
Standard Deviation 13.84
|
1.8 mmHg
Standard Deviation 15.24
|
1.4 mmHg
Standard Deviation 14.17
|
-0.4 mmHg
Standard Deviation 13.83
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
|
1.1 mmHg
Standard Deviation 11.3
|
-0.6 mmHg
Standard Deviation 11.75
|
1.3 mmHg
Standard Deviation 9.61
|
1.5 mmHg
Standard Deviation 11.68
|
0.7 mmHg
Standard Deviation 7.57
|
0.0 mmHg
Standard Deviation 10.62
|
2.3 mmHg
Standard Deviation 9.53
|
-0.3 mmHg
Standard Deviation 9.46
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitPopulation: All safety analyses were carried out using the ITT population, which was defined as all participants who enrolled in Study MT10109L-004 and received at least 1 intervention (MT10109L or placebo) in their prior Phase 3 study (MT10109L-001, -002, -005, or -006) or in the current study. The final outcome measure data reported here are the mean change measured among the participants at day 720 or study exit.
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
|
0.3 breaths/min
Standard Deviation 2.09
|
0.6 breaths/min
Standard Deviation 2.15
|
-0.5 breaths/min
Standard Deviation 1.92
|
0.2 breaths/min
Standard Deviation 2.78
|
0.5 breaths/min
Standard Deviation 1.94
|
-0.4 breaths/min
Standard Deviation 2.29
|
0.4 breaths/min
Standard Deviation 2.21
|
-0.1 breaths/min
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline to Day 720 or Study ExitOnly samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
Outcome measures
| Measure |
Placebo/MT10109L Dose 1
n=55 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 Participants
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 Participants
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 Participants
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 Participants
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 Participants
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Binding and Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo/MT10109L Dose 1
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo/MT10109L Dose 2
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo/MT10109L Dose 1 + Dose 2
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
MT10109L Dose 1/Dose 1
Serious events: 8 serious events
Other events: 54 other events
Deaths: 2 deaths
MT10109L Dose 2/Dose 2
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
MT10109L Dose 1/Dose 1+2
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
MT10109L Dose 2/Dose 1+2
Serious events: 13 serious events
Other events: 60 other events
Deaths: 0 deaths
MT10109L Dose 1+2/Dose 1+2
Serious events: 13 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/MT10109L Dose 1
n=55 participants at risk
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 participants at risk
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 participants at risk
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 participants at risk
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 participants at risk
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 participants at risk
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 participants at risk
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 participants at risk
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.7%
2/116 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.6%
2/128 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Endometritis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.7%
2/118 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.4%
3/123 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.2%
3/253 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.8%
1/56 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.6%
2/123 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.78%
1/128 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.86%
1/116 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/123 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/253 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
Other adverse events
| Measure |
Placebo/MT10109L Dose 1
n=55 participants at risk
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area.
|
Placebo/MT10109L Dose 2
n=56 participants at risk
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
Placebo/MT10109L Dose 1 + Dose 2
n=118 participants at risk
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1
n=116 participants at risk
The participant pool in this arm were from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 1: MT10109L Dose 1 was injected into the GL area
|
MT10109L Dose 2/Dose 2
n=108 participants at risk
The participant pool in this arm were from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continued receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 2: MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 1/Dose 1+2
n=128 participants at risk
The participant pool in this arm were from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
MT10109L Dose 2/Dose 1+2
n=123 participants at risk
The participant pool in this arm were from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area
|
MT10109L Dose 1+2/Dose 1+2
n=253 participants at risk
The participant pool in this arm were from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study received Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1 + Dose 2: MT10109L Dose 1 was injected into the GL area plus MT10109L Dose 2 was injected into the LCL area.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
14.5%
8/55 • Number of events 8 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
8.5%
10/118 • Number of events 10 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
14.7%
17/116 • Number of events 17 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
6.2%
8/128 • Number of events 8 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
13.8%
17/123 • Number of events 17 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
9.1%
23/253 • Number of events 23 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Nervous system disorders
Headache
|
21.8%
12/55 • Number of events 12 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.8%
1/56 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
9.3%
11/118 • Number of events 11 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
10.3%
12/116 • Number of events 12 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.6%
5/108 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
10.2%
13/128 • Number of events 13 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
10.6%
13/123 • Number of events 13 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
10.7%
27/253 • Number of events 27 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.1%
6/118 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.7%
2/116 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.9%
2/108 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.3%
3/128 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.3%
4/123 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.0%
5/253 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Vascular disorders
Hypertension
|
7.3%
4/55 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.6%
2/56 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.5%
3/118 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.3%
5/116 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.8%
3/108 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.3%
3/128 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.9%
6/123 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.6%
9/253 • Number of events 9 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
General disorders
Injection site bruising
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
6.8%
8/118 • Number of events 8 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.6%
3/116 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.1%
4/128 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
9.8%
12/123 • Number of events 12 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
7.9%
20/253 • Number of events 20 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
General disorders
Injection site haemorrhage
|
1.8%
1/55 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.4%
3/56 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
6.8%
8/118 • Number of events 8 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.6%
6/108 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.6%
2/128 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.7%
7/123 • Number of events 7 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.3%
11/253 • Number of events 11 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
COVID-19
|
12.7%
7/55 • Number of events 7 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
21.4%
12/56 • Number of events 12 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
18.6%
22/118 • Number of events 22 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
15.5%
18/116 • Number of events 18 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
28.7%
31/108 • Number of events 31 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
15.6%
20/128 • Number of events 20 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
17.9%
22/123 • Number of events 22 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
18.6%
47/253 • Number of events 47 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
6/55 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
7.1%
4/56 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
12.7%
15/118 • Number of events 15 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
7.8%
9/116 • Number of events 9 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
7.4%
8/108 • Number of events 8 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
7.0%
9/128 • Number of events 9 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
13.8%
17/123 • Number of events 17 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
12.3%
31/253 • Number of events 31 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/55 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
9.3%
11/118 • Number of events 11 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.2%
6/116 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.6%
5/108 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.5%
7/128 • Number of events 7 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
4.1%
5/123 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.9%
15/253 • Number of events 15 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Sinusitis
|
3.6%
2/55 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
8.9%
5/56 • Number of events 5 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.4%
4/118 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.6%
3/116 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.7%
4/108 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.3%
3/128 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.4%
3/123 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.8%
7/253 • Number of events 7 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Infections and infestations
Influenza
|
3.6%
2/55 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
5.1%
6/118 • Number of events 6 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/116 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.6%
2/128 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.81%
1/123 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.40%
1/253 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
5.5%
3/55 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.85%
1/118 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.6%
3/116 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.93%
1/108 • Number of events 1 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.4%
3/123 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
1.2%
3/253 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
5.5%
3/55 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/56 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/118 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
2.6%
3/116 • Number of events 3 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/108 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.00%
0/128 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
3.3%
4/123 • Number of events 4 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
0.79%
2/253 • Number of events 2 • The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.
An AE was considered a TEAE if: * The AE began on or after the date of the first dose of study intervention (lead-in or current study) * The AE was present before the date of the first dose of study intervention in this current study but increased in severity or became serious on or after the date of the first dose of study intervention in the current study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.
- Publication restrictions are in place
Restriction type: OTHER