Trial Outcomes & Findings for A Phase 2 Study of CIM331 for Atopic Dermatitis Patients (NCT NCT01986933)
NCT ID: NCT01986933
Last Updated: 2022-01-25
Results Overview
Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
COMPLETED
PHASE2
264 participants
baseline to Week 12
2022-01-25
Participant Flow
The patients were enrolled at 57 investigational sites in the UK, Germany, Poland, Japan, and the US.
Patient eligibility was assessed during the screening period (Day -28 to Day -8). If all eligibility criteria were met, the patient entered a 7-day run-in period (Day -7 to Day -1) during which all prohibited treatments were discontinued. Baseline assessments were performed until randomization on Day 1.
Participant milestones
| Measure |
Placebo
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Placebo-to-active period (Part B ) (up to Week 64):
Patients randomized to placebo group in Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. Nemoliozumab was given subcutaneously every 4 weeks for 52 weeks. Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.
|
Nemoliozumab (0.1 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (0.5 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (2.0 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (2.0 mg/kg) Q8W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.
|
|---|---|---|---|---|---|
|
Placebo-controlled (Part A)
STARTED
|
53
|
53
|
54
|
52
|
52
|
|
Placebo-controlled (Part A)
COMPLETED
|
44
|
44
|
45
|
45
|
38
|
|
Placebo-controlled (Part A)
NOT COMPLETED
|
9
|
9
|
9
|
7
|
14
|
|
Active-to-active (Part B)
STARTED
|
0
|
41
|
38
|
39
|
35
|
|
Active-to-active (Part B)
COMPLETED
|
0
|
31
|
28
|
30
|
19
|
|
Active-to-active (Part B)
NOT COMPLETED
|
0
|
10
|
10
|
9
|
16
|
|
Placebo-to-active (Part B)
STARTED
|
0
|
13
|
12
|
13
|
0
|
|
Placebo-to-active (Part B)
COMPLETED
|
0
|
8
|
7
|
8
|
0
|
|
Placebo-to-active (Part B)
NOT COMPLETED
|
0
|
5
|
5
|
5
|
0
|
Reasons for withdrawal
| Measure |
Placebo
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Placebo-to-active period (Part B ) (up to Week 64):
Patients randomized to placebo group in Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. Nemoliozumab was given subcutaneously every 4 weeks for 52 weeks. Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.
|
Nemoliozumab (0.1 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (0.5 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (2.0 mg/kg) Q4W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.
|
Nemoliozumab (2.0 mg/kg) Q8W
The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
Active-to-active period (Part B ) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
Placebo-to-active period (Part B) (up to Week 64):
Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.
|
|---|---|---|---|---|---|
|
Placebo-controlled (Part A)
Adverse Event
|
1
|
5
|
2
|
2
|
4
|
|
Placebo-controlled (Part A)
Lack of Efficacy
|
3
|
1
|
1
|
2
|
1
|
|
Placebo-controlled (Part A)
Withdrawal by Subject
|
5
|
2
|
6
|
2
|
7
|
|
Placebo-controlled (Part A)
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
|
Placebo-controlled (Part A)
Others (not classified above reasons)
|
0
|
0
|
0
|
0
|
2
|
|
Active-to-active (Part B)
Adverse Event
|
0
|
2
|
0
|
1
|
3
|
|
Active-to-active (Part B)
Lack of Efficacy
|
0
|
3
|
2
|
0
|
4
|
|
Active-to-active (Part B)
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
|
Active-to-active (Part B)
Physician Decision
|
0
|
0
|
1
|
1
|
0
|
|
Active-to-active (Part B)
Withdrawal by Subject
|
0
|
4
|
7
|
6
|
6
|
|
Active-to-active (Part B)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Active-to-active (Part B)
Others (not classified above reasons)
|
0
|
1
|
0
|
1
|
1
|
|
Placebo-to-active (Part B)
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
|
Placebo-to-active (Part B)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
|
Placebo-to-active (Part B)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Placebo-to-active (Part B)
Withdrawal by Subject
|
0
|
3
|
4
|
3
|
0
|
|
Placebo-to-active (Part B)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=46 Participants
Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=46 Participants
Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=45 Participants
Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=47 Participants
Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q8W (Part A)
n=45 Participants
Data from patients randomized to this group in Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
34.6 years
STANDARD_DEVIATION 13.3 • n=21 Participants
|
34.2 years
STANDARD_DEVIATION 12.1 • n=8 Participants
|
|
Age, Customized
Age Category · < 20 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Age, Customized
Age Category · 20 -< 30 years
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
|
Age, Customized
Age Category · 30 -< 40 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Age, Customized
Age Category · 40 -< 50 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Age, Customized
Age Category · 50 -< 60 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Age, Customized
Age Category · > 60 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
119 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
223 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
70 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
142 Participants
n=8 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=8 Participants
|
|
Height
|
167.81 Centimetre
STANDARD_DEVIATION 8.84 • n=5 Participants
|
170.19 Centimetre
STANDARD_DEVIATION 10.52 • n=7 Participants
|
167.41 Centimetre
STANDARD_DEVIATION 9.44 • n=5 Participants
|
170.04 Centimetre
STANDARD_DEVIATION 8.84 • n=4 Participants
|
167.58 Centimetre
STANDARD_DEVIATION 9.63 • n=21 Participants
|
168.62 Centimetre
STANDARD_DEVIATION 9.47 • n=8 Participants
|
|
Weight
|
74.20 Kilogram
STANDARD_DEVIATION 21.60 • n=5 Participants
|
76.01 Kilogram
STANDARD_DEVIATION 22.90 • n=7 Participants
|
73.40 Kilogram
STANDARD_DEVIATION 19.98 • n=5 Participants
|
72.51 Kilogram
STANDARD_DEVIATION 16.04 • n=4 Participants
|
72.63 Kilogram
STANDARD_DEVIATION 20.96 • n=21 Participants
|
73.75 Kilogram
STANDARD_DEVIATION 20.27 • n=8 Participants
|
|
Weight Category
< 60 kg
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Weight Category
>- 60 kg
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
165 Participants
n=8 Participants
|
|
Body mass index
|
26.20 Kilogram per square metre
STANDARD_DEVIATION 6.81 • n=5 Participants
|
25.92 Kilogram per square metre
STANDARD_DEVIATION 6.41 • n=7 Participants
|
26.10 Kilogram per square metre
STANDARD_DEVIATION 6.66 • n=5 Participants
|
25.08 Kilogram per square metre
STANDARD_DEVIATION 5.26 • n=4 Participants
|
25.71 Kilogram per square metre
STANDARD_DEVIATION 6.47 • n=21 Participants
|
25.80 Kilogram per square metre
STANDARD_DEVIATION 6.30 • n=8 Participants
|
|
Body Mass Index Category
< 25 kg/m^2
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
127 Participants
n=8 Participants
|
|
Body Mass Index Category
>- 25 kg/m^2
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
102 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline to Week 12Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=43 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=44 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=43 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
|
-20.07 percentage change
Interval -29.94 to -10.21
|
-41.46 percentage change
Interval -51.21 to -31.71
|
-61.24 percentage change
Interval -71.13 to -51.35
|
-60.46 percentage change
Interval -69.98 to -50.95
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A)Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=45 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=47 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
Week 4
|
-12.12 percentage change from baseline
Standard Deviation 40.00
|
-26.89 percentage change from baseline
Standard Deviation 44.48
|
-35.70 percentage change from baseline
Standard Deviation 44.29
|
-33.86 percentage change from baseline
Standard Deviation 34.14
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
Week 8
|
-21.82 percentage change from baseline
Standard Deviation 47.00
|
-25.17 percentage change from baseline
Standard Deviation 51.79
|
-46.20 percentage change from baseline
Standard Deviation 42.62
|
-39.89 percentage change from baseline
Standard Deviation 34.43
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
Week 12
|
-20.89 percentage change from baseline
Standard Deviation 47.63
|
-27.88 percentage change from baseline
Standard Deviation 50.50
|
-44.57 percentage change from baseline
Standard Deviation 48.21
|
-40.29 percentage change from baseline
Standard Deviation 37.70
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A), up to Week 64 (Part B)Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=53 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=54 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 4
|
-25.47 percentage change from baseline
Standard Deviation 42.41
|
-32.11 percentage change from baseline
Standard Deviation 43.70
|
-32.48 percentage change from baseline
Standard Deviation 34.02
|
-25.43 percentage change from baseline
Standard Deviation 35.58
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 8
|
-25.13 percentage change from baseline
Standard Deviation 49.82
|
-47.86 percentage change from baseline
Standard Deviation 41.38
|
-41.02 percentage change from baseline
Standard Deviation 36.50
|
-33.35 percentage change from baseline
Standard Deviation 38.00
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 12
|
-35.11 percentage change from baseline
Standard Deviation 47.92
|
-47.75 percentage change from baseline
Standard Deviation 45.41
|
-46.78 percentage change from baseline
Standard Deviation 35.15
|
-42.12 percentage change from baseline
Standard Deviation 40.82
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 24
|
-55.83 percentage change from baseline
Standard Deviation 42.25
|
-62.71 percentage change from baseline
Standard Deviation 44.37
|
-56.26 percentage change from baseline
Standard Deviation 34.68
|
-51.01 percentage change from baseline
Standard Deviation 37.07
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 48
|
-69.90 percentage change from baseline
Standard Deviation 28.17
|
-71.16 percentage change from baseline
Standard Deviation 43.31
|
-61.14 percentage change from baseline
Standard Deviation 44.43
|
-74.29 percentage change from baseline
Standard Deviation 33.97
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 60
|
-63.11 percentage change from baseline
Standard Deviation 41.89
|
-78.81 percentage change from baseline
Standard Deviation 28.82
|
-70.85 percentage change from baseline
Standard Deviation 36.24
|
-70.87 percentage change from baseline
Standard Deviation 32.84
|
|
Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
Week 64
|
-68.45 percentage change from baseline
Standard Deviation 41.62
|
-75.79 percentage change from baseline
Standard Deviation 25.40
|
-78.91 percentage change from baseline
Standard Deviation 24.34
|
-69.25 percentage change from baseline
Standard Deviation 43.96
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A)Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=45 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=47 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
Week 4
|
-6.83 percentage change from baseline
Standard Deviation 25.97
|
-29.31 percentage change from baseline
Standard Deviation 23.58
|
-34.59 percentage change from baseline
Standard Deviation 29.36
|
-29.82 percentage change from baseline
Standard Deviation 21.65
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
Week 8
|
-17.29 percentage change from baseline
Standard Deviation 30.74
|
-26.41 percentage change from baseline
Standard Deviation 26.60
|
-36.81 percentage change from baseline
Standard Deviation 29.04
|
-34.72 percentage change from baseline
Standard Deviation 24.33
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
Week 12
|
-15.97 percentage change from baseline
Standard Deviation 26.99
|
-27.22 percentage change from baseline
Standard Deviation 25.81
|
-39.49 percentage change from baseline
Standard Deviation 32.68
|
-38.31 percentage change from baseline
Standard Deviation 28.85
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A), up to Week 64 (Part B)Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \[\<25\], moderate \[25-50\] or severe \[\>50\]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=53 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=54 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 4
|
-27.73 percentage change from baseline
Standard Deviation 23.92
|
-30.30 percentage change from baseline
Standard Deviation 30.39
|
-28.20 percentage change from baseline
Standard Deviation 22.65
|
-25.31 percentage change from baseline
Standard Deviation 22.68
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 8
|
-29.05 percentage change from baseline
Standard Deviation 27.17
|
-36.16 percentage change from baseline
Standard Deviation 28.60
|
-37.52 percentage change from baseline
Standard Deviation 23.34
|
-31.81 percentage change from baseline
Standard Deviation 28.42
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 12
|
-36.35 percentage change from baseline
Standard Deviation 22.24
|
-42.22 percentage change from baseline
Standard Deviation 30.72
|
-42.60 percentage change from baseline
Standard Deviation 27.12
|
-41.85 percentage change from baseline
Standard Deviation 20.79
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 24
|
-48.73 percentage change from baseline
Standard Deviation 27.64
|
-58.15 percentage change from baseline
Standard Deviation 28.15
|
-52.00 percentage change from baseline
Standard Deviation 24.97
|
-49.97 percentage change from baseline
Standard Deviation 24.99
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 48
|
-55.82 percentage change from baseline
Standard Deviation 24.21
|
-59.20 percentage change from baseline
Standard Deviation 28.61
|
-53.82 percentage change from baseline
Standard Deviation 29.98
|
-66.15 percentage change from baseline
Standard Deviation 24.43
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 60
|
-55.08 percentage change from baseline
Standard Deviation 24.22
|
-64.02 percentage change from baseline
Standard Deviation 24.24
|
-63.26 percentage change from baseline
Standard Deviation 25.04
|
-61.03 percentage change from baseline
Standard Deviation 24.27
|
|
Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
Week 64
|
-56.55 percentage change from baseline
Standard Deviation 28.25
|
-64.02 percentage change from baseline
Standard Deviation 27.72
|
-66.61 percentage change from baseline
Standard Deviation 19.90
|
-63.07 percentage change from baseline
Standard Deviation 27.96
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A)Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=45 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=47 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
Week 4
|
-0.2 change from baseline
Standard Deviation 0.8
|
-0.8 change from baseline
Standard Deviation 0.9
|
-0.9 change from baseline
Standard Deviation 0.9
|
-0.6 change from baseline
Standard Deviation 0.9
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
Week 8
|
-0.5 change from baseline
Standard Deviation 1.2
|
-0.7 change from baseline
Standard Deviation 1.0
|
-1.0 change from baseline
Standard Deviation 1.2
|
-0.8 change from baseline
Standard Deviation 1.0
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
Week 12
|
-0.3 change from baseline
Standard Deviation 1.0
|
-0.7 change from baseline
Standard Deviation 1.0
|
-1.0 change from baseline
Standard Deviation 1.1
|
-0.8 change from baseline
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A), up to Week 64 (Part B)Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).
Outcome measures
| Measure |
Placebo (Part A)
n=53 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=54 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 48
|
-1.7 change from baseline
Standard Deviation 1.2
|
-1.8 change from baseline
Standard Deviation 0.8
|
-1.4 change from baseline
Standard Deviation 1.2
|
-2.0 change from baseline
Standard Deviation 1.2
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 60
|
-1.9 change from baseline
Standard Deviation 1.0
|
-2.0 change from baseline
Standard Deviation 0.9
|
-1.7 change from baseline
Standard Deviation 1.1
|
-1.7 change from baseline
Standard Deviation 1.1
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 64
|
-1.9 change from baseline
Standard Deviation 1.1
|
-1.9 change from baseline
Standard Deviation 0.9
|
-1.7 change from baseline
Standard Deviation 1.0
|
-1.8 change from baseline
Standard Deviation 1.3
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 4
|
-0.7 change from baseline
Standard Deviation 0.9
|
-0.8 change from baseline
Standard Deviation 0.9
|
-0.6 change from baseline
Standard Deviation 0.9
|
-0.4 change from baseline
Standard Deviation 0.8
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 8
|
-0.8 change from baseline
Standard Deviation 1.0
|
-1.0 change from baseline
Standard Deviation 1.2
|
-0.9 change from baseline
Standard Deviation 0.9
|
-0.5 change from baseline
Standard Deviation 0.9
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 12
|
-0.9 change from baseline
Standard Deviation 0.9
|
-1.1 change from baseline
Standard Deviation 1.1
|
-0.9 change from baseline
Standard Deviation 1.0
|
-0.9 change from baseline
Standard Deviation 0.8
|
|
Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
Week 24
|
-1.5 change from baseline
Standard Deviation 1.1
|
-1.7 change from baseline
Standard Deviation 1.0
|
-1.2 change from baseline
Standard Deviation 1.0
|
-1.2 change from baseline
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A)Population: The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Outcome measures
| Measure |
Placebo (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=46 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=45 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=47 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
Week 4
|
-7.48 percentage change from baseline
Standard Deviation 37.14
|
-12.11 percentage change from baseline
Standard Deviation 43.69
|
-23.49 percentage change from baseline
Standard Deviation 40.93
|
-18.44 percentage change from baseline
Standard Deviation 35.47
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
Week 8
|
-14.44 percentage change from baseline
Standard Deviation 49.29
|
-14.90 percentage change from baseline
Standard Deviation 45.84
|
-27.23 percentage change from baseline
Standard Deviation 47.17
|
-22.99 percentage change from baseline
Standard Deviation 38.58
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
Week 12
|
-13.29 percentage change from baseline
Standard Deviation 49.87
|
-17.54 percentage change from baseline
Standard Deviation 47.16
|
-19.68 percentage change from baseline
Standard Deviation 67.49
|
-24.36 percentage change from baseline
Standard Deviation 41.84
|
SECONDARY outcome
Timeframe: baseline to Week 12 (Part A), up to Week 64 (Part B)Population: The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.
The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).
Outcome measures
| Measure |
Placebo (Part A)
n=53 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=54 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 Participants
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
|---|---|---|---|---|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 60
|
-60.41 percentage change from baseline
Standard Deviation 37.00
|
-70.44 percentage change from baseline
Standard Deviation 35.81
|
-60.99 percentage change from baseline
Standard Deviation 48.00
|
-58.38 percentage change from baseline
Standard Deviation 44.97
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 48
|
-65.21 percentage change from baseline
Standard Deviation 32.63
|
-69.20 percentage change from baseline
Standard Deviation 39.95
|
-49.66 percentage change from baseline
Standard Deviation 44.18
|
-59.97 percentage change from baseline
Standard Deviation 50.32
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 12
|
-24.53 percentage change from baseline
Standard Deviation 49.77
|
-25.31 percentage change from baseline
Standard Deviation 63.43
|
-25.91 percentage change from baseline
Standard Deviation 44.40
|
-18.56 percentage change from baseline
Standard Deviation 52.30
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 64
|
-62.54 percentage change from baseline
Standard Deviation 40.92
|
-66.01 percentage change from baseline
Standard Deviation 36.38
|
-63.35 percentage change from baseline
Standard Deviation 40.37
|
-60.54 percentage change from baseline
Standard Deviation 55.96
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 24
|
-48.13 percentage change from baseline
Standard Deviation 39.07
|
-51.41 percentage change from baseline
Standard Deviation 44.10
|
-40.53 percentage change from baseline
Standard Deviation 42.94
|
-36.91 percentage change from baseline
Standard Deviation 40.99
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 4
|
-10.12 percentage change from baseline
Standard Deviation 45.56
|
-23.28 percentage change from baseline
Standard Deviation 38.96
|
-17.98 percentage change from baseline
Standard Deviation 35.12
|
-2.79 percentage change from baseline
Standard Deviation 54.12
|
|
Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
Week 8
|
-18.08 percentage change from baseline
Standard Deviation 45.82
|
-29.58 percentage change from baseline
Standard Deviation 47.13
|
-24.64 percentage change from baseline
Standard Deviation 37.49
|
-6.66 percentage change from baseline
Standard Deviation 59.40
|
Adverse Events
Placebo (Part A)
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
Nemoliozumab (2.0 mg/kg) Q8W (Part A)
Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)
Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)
Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)
Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)
Serious adverse events
| Measure |
Placebo (Part A)
n=53 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=53 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=54 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q8W (Part A)
n=52 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)
n=53 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)
n=54 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)
n=52 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)
n=52 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Skin infection
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Infection
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Eye disorders
Cataract
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Eye disorders
Retinal detachment
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
Other adverse events
| Measure |
Placebo (Part A)
n=53 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A)
n=53 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A)
n=54 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A)
n=52 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
|
Nemoliozumab (2.0 mg/kg) Q8W (Part A)
n=52 participants at risk
Data from Part A and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
|
Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)
n=53 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)
n=54 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)
n=52 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)
n=52 participants at risk
Data from Part A, Part B and Safety Follow-up period were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.
Active-to-active period (Part B) (up to Week 64):
Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.1%
8/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
17.0%
9/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.1%
6/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
13.5%
7/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
28.3%
15/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
25.9%
14/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
28.8%
15/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
23.1%
12/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
6/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
7.5%
4/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
7.7%
4/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.3%
6/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Impetigo
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
7.5%
4/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.3%
6/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Influenza
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.4%
5/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.7%
2/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Cystitis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Infections and infestations
Folliculitis
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
13.2%
7/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
20.8%
11/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
18.5%
10/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
17.3%
9/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
17.3%
9/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
28.3%
15/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
22.2%
12/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
23.1%
12/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
17.3%
9/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
General disorders
Oedema peripheral
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.5%
6/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.7%
2/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
7.7%
4/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.4%
5/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
17.3%
9/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.5%
6/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Nervous system disorders
Headache
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.7%
2/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
11.1%
6/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
9.6%
5/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.6%
3/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
0.00%
0/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.7%
2/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.8%
3/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
5.7%
3/53 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/54 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
1.9%
1/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
3.8%
2/52 • baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality. Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER