Trial Outcomes & Findings for An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma (NCT NCT01854047)
NCT ID: NCT01854047
Last Updated: 2017-06-26
Results Overview
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
776 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2017-06-26
Participant Flow
The study was conducted at 201 sites in 16 countries. A total of 1532 participants were screened between June 2013 and June 2014, of which, 776 participants were randomized at 174 sites in 15 countries. 756 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.
Randomization was stratified using blood eosinophils count (eosinophils \>=0.3 Giga/L \[G/L\]; eosinophils 0.2 to 0.299 G/L; eosinophils\<0.2 G/L) and country. Assignment was done by Interactive Voice/Web Response System (1:1:1:1:1) for Placebo and Dupilumab (300 mg every 2 weeks \[q2w\]; 200 mg q2w; 300 mg every 4 week \[q4w\] and 200 mg q4w).
Participant milestones
| Measure |
Placebo q2w
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
158
|
157
|
150
|
157
|
154
|
|
Overall Study
Treated
|
158
|
156
|
148
|
157
|
150
|
|
Overall Study
Completed 12-week Study Treatment
|
153
|
149
|
141
|
146
|
143
|
|
Overall Study
COMPLETED
|
146
|
149
|
137
|
142
|
135
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
13
|
15
|
19
|
Reasons for withdrawal
| Measure |
Placebo q2w
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Poor compliance to protocol
|
3
|
0
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
4
|
6
|
10
|
7
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
2
|
0
|
4
|
|
Overall Study
Other than specified above
|
3
|
3
|
3
|
5
|
8
|
Baseline Characteristics
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Total
n=776 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
51 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
48.6 years
STANDARD_DEVIATION 13.0 • n=10 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
490 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
286 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
115 Participants
n=10 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
607 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic Or Latino
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
148 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
628 Participants
n=10 Participants
|
|
Number of Participants According to Blood Eosinophil Count
<0.3 G/L
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
451 Participants
n=10 Participants
|
|
Number of Participants According to Blood Eosinophil Count
>=0.3 G/L
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
325 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT population: subset of intent to treat (ITT) population (defined as randomized population analyzed according to the treatment group allocated by randomization, regardless of whether the treatment was actually received) which included participants with baseline blood eosinophils \>=0.3 G/L.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
Baseline
|
1.86 liter
Standard Deviation 0.68
|
1.77 liter
Standard Deviation 0.5
|
1.8 liter
Standard Deviation 0.52
|
1.87 liter
Standard Deviation 0.6
|
1.8 liter
Standard Deviation 0.49
|
|
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
Week 12
|
2.13 liter
Standard Deviation 0.78
|
2.12 liter
Standard Deviation 0.54
|
2.26 liter
Standard Deviation 0.68
|
2.26 liter
Standard Deviation 0.70
|
2.09 liter
Standard Deviation 0.54
|
|
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
Change from baseline at Week 12
|
0.18 liter
Standard Deviation 0.38
|
0.36 liter
Standard Deviation 0.46
|
0.45 liter
Standard Deviation 0.40
|
0.35 liter
Standard Deviation 0.43
|
0.26 liter
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Baseline
|
1.82 liter
Standard Deviation 0.55
|
1.85 liter
Standard Deviation 0.53
|
1.79 liter
Standard Deviation 0.52
|
1.86 liter
Standard Deviation 0.57
|
1.88 liter
Standard Deviation 0.54
|
|
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Week 12
|
2.01 liter
Standard Deviation 0.69
|
2.12 liter
Standard Deviation 0.59
|
2.12 liter
Standard Deviation 0.68
|
2.14 liter
Standard Deviation 0.69
|
2.07 liter
Standard Deviation 0.63
|
|
Absolute Change From Baseline in FEV1 at Week 12: ITT Population
Change from baseline at Week 12
|
0.13 liter
Standard Deviation 0.37
|
0.26 liter
Standard Deviation 0.39
|
0.32 liter
Standard Deviation 0.38
|
0.24 liter
Standard Deviation 0.4
|
0.20 liter
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=58 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=59 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=57 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=55 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=53 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
|
10.07 percent change
Standard Deviation 19.65
|
25.29 percent change
Standard Deviation 36.15
|
27.42 percent change
Standard Deviation 25.68
|
20.68 percent change
Standard Deviation 24.86
|
18.07 percent change
Standard Deviation 29.18
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=129 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=146 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=136 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=134 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=134 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in FEV1 at Week 12: ITT Population
|
7.04 percent change
Standard Deviation 19.26
|
16.64 percent change
Standard Deviation 27.78
|
19.15 percent change
Standard Deviation 23.53
|
13.55 percent change
Standard Deviation 23.01
|
13.04 percent change
Standard Deviation 24.21
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated.
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=59 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
|
1.044 exacerbation per participant-year
Interval 0.572 to 1.904
|
0.201 exacerbation per participant-year
Interval 0.078 to 0.517
|
0.30 exacerbation per participant-year
Interval 0.133 to 0.678
|
0.678 exacerbation per participant-year
Interval 0.356 to 1.29
|
0.358 exacerbation per participant-year
Interval 0.158 to 0.809
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=156 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=148 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
|
0.897 exacerbation per participant-year
Interval 0.619 to 1.3
|
0.265 exacerbation per participant-year
Interval 0.157 to 0.445
|
0.269 exacerbation per participant-year
Interval 0.157 to 0.461
|
0.599 exacerbation per participant-year
Interval 0.369 to 0.907
|
0.415 exacerbation per participant-year
Interval 0.26 to 0.664
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated.
The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=59 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Probability at Week 12
|
0.21 probability of Severe Exacerbation
Interval 0.122 to 0.314
|
0.082 probability of Severe Exacerbation
Interval 0.03 to 0.167
|
0.082 probability of Severe Exacerbation
Interval 0.03 to 0.167
|
0.094 probability of Severe Exacerbation
Interval 0.038 to 0.181
|
0.052 probability of Severe Exacerbation
Interval 0.014 to 0.13
|
|
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
Probability at Week 24
|
0.287 probability of Severe Exacerbation
Interval 0.184 to 0.398
|
0.116 probability of Severe Exacerbation
Interval 0.051 to 0.21
|
0.082 probability of Severe Exacerbation
Interval 0.03 to 0.167
|
0.175 probability of Severe Exacerbation
Interval 0.093 to 0.278
|
0.125 probability of Severe Exacerbation
Interval 0.055 to 0.226
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated.
The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=156 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=148 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
Probability at Week 12
|
0.207 probability of Severe Exacerbation
Interval 0.147 to 0.274
|
0.092 probability of Severe Exacerbation
Interval 0.053 to 0.145
|
0.07 probability of Severe Exacerbation
Interval 0.036 to 0.119
|
0.112 probability of Severe Exacerbation
Interval 0.068 to 0.168
|
0.075 probability of Severe Exacerbation
Interval 0.04 to 0.125
|
|
Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
Probability at Week 24
|
0.266 probability of Severe Exacerbation
Interval 0.199 to 0.338
|
0.112 probability of Severe Exacerbation
Interval 0.068 to 0.169
|
0.091 probability of Severe Exacerbation
Interval 0.051 to 0.145
|
0.195 probability of Severe Exacerbation
Interval 0.136 to 0.262
|
0.16 probability of Severe Exacerbation
Interval 0.106 to 0.225
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated.
LOAC was defined as any of the following: \>=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) \>=4 times the dose at randomization; use of systemic corticosteroids for \>=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=59 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population
|
1.312 LOAC per participant-year
Interval 0.804 to 2.142
|
0.322 LOAC per participant-year
Interval 0.153 to 0.677
|
0.446 LOAC per participant-year
Interval 0.231 to 0.864
|
0.788 LOAC per participant-year
Interval 0.458 to 1.355
|
0.424 LOAC per participant-year
Interval 0.212 to 0.851
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
LOAC was defined as any of the following: \>=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times the dose at randomization; use of systemic corticosteroids for \>=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=156 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=148 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Annualized Event Rate of LOAC During The Treatment Period: ITT Population
|
1.107 LOAC per participant-year
Interval 0.801 to 1.53
|
0.326 LOAC per participant-year
Interval 0.206 to 0.515
|
0.347 LOAC per participant-year
Interval 0.217 to 0.555
|
0.73 LOAC per participant-year
Interval 0.508 to 1.048
|
0.563 LOAC per participant-year
Interval 0.378 to 0.839
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: HEos-ITT population. Here 'overall number of participants analyzed' signifies participants of the HEos-ITT population who were treated.
The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=59 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
Probability at Week 12
|
0.30 probability of LOAC
Interval 0.195 to 0.411
|
0.115 probability of LOAC
Interval 0.05 to 0.208
|
0.113 probability of LOAC
Interval 0.05 to 0.206
|
0.126 probability of LOAC
Interval 0.059 to 0.22
|
0.052 probability of LOAC
Interval 0.014 to 0.13
|
|
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
Probability at Week 24
|
0.392 probability of LOAC
Interval 0.275 to 0.507
|
0.166 probability of LOAC
Interval 0.085 to 0.269
|
0.113 probability of LOAC
Interval 0.05 to 0.206
|
0.207 probability of LOAC
Interval 0.117 to 0.314
|
0.162 probability of LOAC
Interval 0.079 to 0.269
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.
The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=156 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=148 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
Probability at Week 12
|
0.258 probability of LOAC
Interval 0.192 to 0.329
|
0.112 probability of LOAC
Interval 0.068 to 0.168
|
0.09 probability of LOAC
Interval 0.051 to 0.144
|
0.145 probability of LOAC
Interval 0.095 to 0.206
|
0.096 probability of LOAC
Interval 0.055 to 0.15
|
|
Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
Probability at Week 24
|
0.338 probability of LOAC
Interval 0.265 to 0.413
|
0.146 probability of LOAC
Interval 0.095 to 0.207
|
0.112 probability of LOAC
Interval 0.067 to 0.169
|
0.242 probability of LOAC
Interval 0.177 to 0.314
|
0.209 probability of LOAC
Interval 0.147 to 0.279
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT population.
Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Week 12
|
0.83 scores on a scale
Standard Deviation 0.66
|
0.78 scores on a scale
Standard Deviation 0.88
|
0.70 scores on a scale
Standard Deviation 0.69
|
0.70 scores on a scale
Standard Deviation 0.78
|
0.63 scores on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Baseline
|
1.15 scores on a scale
Standard Deviation 0.82
|
1.45 scores on a scale
Standard Deviation 0.81
|
1.22 scores on a scale
Standard Deviation 0.81
|
1.31 scores on a scale
Standard Deviation 0.72
|
1.18 scores on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
Change from baseline at Week 12
|
-0.29 scores on a scale
Standard Deviation 0.70
|
-0.66 scores on a scale
Standard Deviation 0.67
|
-0.55 scores on a scale
Standard Deviation 0.75
|
-0.57 scores on a scale
Standard Deviation 0.63
|
-0.57 scores on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Baseline
|
1.17 scores on a scale
Standard Deviation 0.79
|
1.25 scores on a scale
Standard Deviation 0.78
|
1.24 scores on a scale
Standard Deviation 0.81
|
1.33 scores on a scale
Standard Deviation 0.78
|
1.29 scores on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Week 12
|
0.90 scores on a scale
Standard Deviation 0.67
|
0.82 scores on a scale
Standard Deviation 0.79
|
0.79 scores on a scale
Standard Deviation 0.77
|
0.80 scores on a scale
Standard Deviation 0.73
|
0.72 scores on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
Change from baseline at Week 12
|
-0.23 scores on a scale
Standard Deviation 0.70
|
-0.43 scores on a scale
Standard Deviation 0.70
|
-0.46 scores on a scale
Standard Deviation 0.75
|
-0.52 scores on a scale
Standard Deviation 0.65
|
-0.54 scores on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos ITT population.
Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Baseline
|
1.33 scores on a scale
Standard Deviation 0.83
|
1.72 scores on a scale
Standard Deviation 0.89
|
1.46 scores on a scale
Standard Deviation 0.73
|
1.52 scores on a scale
Standard Deviation 0.72
|
1.39 scores on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Week 12
|
0.95 scores on a scale
Standard Deviation 0.71
|
0.88 scores on a scale
Standard Deviation 0.91
|
0.89 scores on a scale
Standard Deviation 0.79
|
0.76 scores on a scale
Standard Deviation 0.84
|
0.69 scores on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
Change from baseline at Week 12
|
-0.35 scores on a scale
Standard Deviation 0.71
|
-0.84 scores on a scale
Standard Deviation 0.87
|
-0.62 scores on a scale
Standard Deviation 0.70
|
-0.73 scores on a scale
Standard Deviation 0.77
|
-0.69 scores on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Baseline
|
1.32 scores on a scale
Standard Deviation 0.81
|
1.47 scores on a scale
Standard Deviation 0.85
|
1.42 scores on a scale
Standard Deviation 0.79
|
1.50 scores on a scale
Standard Deviation 0.74
|
1.47 scores on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Week 12
|
1.02 scores on a scale
Standard Deviation 0.73
|
0.95 scores on a scale
Standard Deviation 0.88
|
0.95 scores on a scale
Standard Deviation 0.81
|
0.89 scores on a scale
Standard Deviation 0.79
|
0.89 scores on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
Change from baseline at Week 12
|
-0.27 scores on a scale
Standard Deviation 0.76
|
-0.52 scores on a scale
Standard Deviation 0.79
|
-0.52 scores on a scale
Standard Deviation 0.80
|
-0.59 scores on a scale
Standard Deviation 0.79
|
-0.54 scores on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT population.
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Baseline
|
2.55 scores on a scale
Standard Deviation 0.84
|
2.98 scores on a scale
Standard Deviation 0.90
|
2.65 scores on a scale
Standard Deviation 0.74
|
2.69 scores on a scale
Standard Deviation 0.81
|
2.76 scores on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Week 12
|
1.52 scores on a scale
Standard Deviation 1.09
|
1.20 scores on a scale
Standard Deviation 0.96
|
1.20 scores on a scale
Standard Deviation 0.88
|
1.27 scores on a scale
Standard Deviation 0.91
|
1.39 scores on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
Change from baseline at Week 12
|
-1.03 scores on a scale
Standard Deviation 0.93
|
-1.72 scores on a scale
Standard Deviation 1.14
|
-1.40 scores on a scale
Standard Deviation 1.03
|
-1.39 scores on a scale
Standard Deviation 1.02
|
-1.38 scores on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Baseline
|
2.69 scores on a scale
Standard Deviation 0.80
|
2.80 scores on a scale
Standard Deviation 0.83
|
2.73 scores on a scale
Standard Deviation 0.82
|
2.70 scores on a scale
Standard Deviation 0.79
|
2.78 scores on a scale
Standard Deviation 0.84
|
|
Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Week 12
|
1.55 scores on a scale
Standard Deviation 1.00
|
1.41 scores on a scale
Standard Deviation 1.02
|
1.38 scores on a scale
Standard Deviation 0.96
|
1.38 scores on a scale
Standard Deviation 0.86
|
1.49 scores on a scale
Standard Deviation 0.98
|
|
Change From Baseline in ACQ-5 Score at Week 12: ITT Population
Change from baseline at Week 12
|
-1.11 scores on a scale
Standard Deviation 0.93
|
-1.38 scores on a scale
Standard Deviation 1.10
|
-1.35 scores on a scale
Standard Deviation 1.05
|
-1.32 scores on a scale
Standard Deviation 1.02
|
-1.24 scores on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT population.
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Baseline
|
4.16 scores on a scale
Standard Deviation 1.27
|
3.82 scores on a scale
Standard Deviation 1.13
|
4.02 scores on a scale
Standard Deviation 1.15
|
3.99 scores on a scale
Standard Deviation 1.06
|
3.89 scores on a scale
Standard Deviation 1.88
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Week 12
|
5.05 scores on a scale
Standard Deviation 1.22
|
5.35 scores on a scale
Standard Deviation 1.21
|
5.41 scores on a scale
Standard Deviation 1.06
|
5.06 scores on a scale
Standard Deviation 1.19
|
5.05 scores on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
Change from baseline at Week 12
|
0.80 scores on a scale
Standard Deviation 1.02
|
1.54 scores on a scale
Standard Deviation 1.18
|
1.42 scores on a scale
Standard Deviation 0.97
|
1.08 scores on a scale
Standard Deviation 0.97
|
1.16 scores on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Baseline
|
4.12 scores on a scale
Standard Deviation 1.10
|
3.91 scores on a scale
Standard Deviation 1.13
|
4.03 scores on a scale
Standard Deviation 1.15
|
4.02 scores on a scale
Standard Deviation 1.01
|
4.00 scores on a scale
Standard Deviation 1.09
|
|
Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Week 12
|
5.00 scores on a scale
Standard Deviation 1.10
|
5.13 scores on a scale
Standard Deviation 1.22
|
5.22 scores on a scale
Standard Deviation 1.11
|
5.04 scores on a scale
Standard Deviation 1.13
|
5.03 scores on a scale
Standard Deviation 1.12
|
|
Change From Baseline in AQLQ Global Score at Week 12: ITT Population
Change from baseline at Week 12
|
0.86 scores on a scale
Standard Deviation 0.99
|
1.25 scores on a scale
Standard Deviation 1.10
|
1.19 scores on a scale
Standard Deviation 1.05
|
1.03 scores on a scale
Standard Deviation 1.02
|
0.98 scores on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: HEos-ITT Population.
Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.
Outcome measures
| Measure |
Placebo q2w
n=68 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=64 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=65 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=66 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=62 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Baseline
|
2.53 inhalations per day
Standard Deviation 2.77
|
3.61 inhalations per day
Standard Deviation 3.56
|
3.02 inhalations per day
Standard Deviation 2.85
|
3.15 inhalations per day
Standard Deviation 2.70
|
2.42 inhalations per day
Standard Deviation 2.75
|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Week 12
|
1.88 inhalations per day
Standard Deviation 2.53
|
2.14 inhalations per day
Standard Deviation 3.22
|
2.15 inhalations per day
Standard Deviation 2.67
|
1.85 inhalations per day
Standard Deviation 2.75
|
1.36 inhalations per day
Standard Deviation 1.76
|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
Change from baseline at Week 12
|
-0.51 inhalations per day
Standard Deviation 1.74
|
-1.47 inhalations per day
Standard Deviation 2.31
|
-0.93 inhalations per day
Standard Deviation 2.31
|
-1.49 inhalations per day
Standard Deviation 2.37
|
-1.01 inhalations per day
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population.
Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.
Outcome measures
| Measure |
Placebo q2w
n=158 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=150 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=157 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=154 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Baseline
|
2.72 inhalations per day
Standard Deviation 2.73
|
3.25 inhalations per day
Standard Deviation 3.15
|
2.98 inhalations per day
Standard Deviation 2.74
|
3.36 inhalations per day
Standard Deviation 3.43
|
3.01 inhalations per day
Standard Deviation 2.87
|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Week 12
|
2.20 inhalations per day
Standard Deviation 2.57
|
2.30 inhalations per day
Standard Deviation 3.02
|
2.03 inhalations per day
Standard Deviation 2.46
|
2.09 inhalations per day
Standard Deviation 2.73
|
1.99 inhalations per day
Standard Deviation 2.42
|
|
Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
Change from baseline at Week 12
|
-0.44 inhalations per day
Standard Deviation 1.75
|
-0.95 inhalations per day
Standard Deviation 2.05
|
-0.99 inhalations per day
Standard Deviation 2.27
|
-1.35 inhalations per day
Standard Deviation 2.84
|
-0.92 inhalations per day
Standard Deviation 2.16
|
POST_HOC outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count \<0.3 G/L.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Outcome measures
| Measure |
Placebo q2w
n=90 Participants
2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q2w
n=93 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q2w
n=85 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 300 mg q4w
n=91 Participants
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
Dupilumab 200 mg q4w
n=92 Participants
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L
Baseline
|
1.79 liter
Standard Deviation 0.42
|
1.9 liter
Standard Deviation 0.55
|
1.79 liter
Standard Deviation 0.53
|
1.85 liter
Standard Deviation 0.56
|
1.94 liter
Standard Deviation 0.56
|
|
Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L
Week 12
|
1.92 liter
Standard Deviation 0.61
|
2.12 liter
Standard Deviation 0.63
|
2.02 liter
Standard Deviation 0.67
|
2.05 liter
Standard Deviation 0.68
|
2.06 liter
Standard Deviation 0.68
|
|
Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L
Change from baseline at Week 12
|
0.09 liter
Standard Deviation 0.36
|
0.19 liter
Standard Deviation 0.31
|
0.23 liter
Standard Deviation 0.33
|
0.16 liter
Standard Deviation 0.36
|
0.17 liter
Standard Deviation 0.36
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 88 other events
Deaths: 0 deaths
Dupilumab 300 mg q2w
Serious events: 13 serious events
Other events: 95 other events
Deaths: 0 deaths
Dupilumab 200 mg q2w
Serious events: 10 serious events
Other events: 81 other events
Deaths: 0 deaths
Dupilumab 300 mg q4w
Serious events: 16 serious events
Other events: 96 other events
Deaths: 2 deaths
Dupilumab 200 mg q4w
Serious events: 6 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=158 participants at risk
Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 300 mg q2w
n=156 participants at risk
Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 200 mg q2w
n=148 participants at risk
Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 300 mg q4w
n=157 participants at risk
Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 200 mg q4w
n=150 participants at risk
Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.3%
2/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Herpes zoster
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.67%
1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Nervous system disorders
Syncope
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.67%
1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Cardiac disorders
Cor pulmonale acute
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Vascular disorders
Hypertension
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
4/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.4%
5/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.3%
2/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.3%
2/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.67%
1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.4%
2/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Investigations
Blood pressure increased
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.67%
1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.64%
1/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.67%
1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
Other adverse events
| Measure |
Placebo
n=158 participants at risk
Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 300 mg q2w
n=156 participants at risk
Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 200 mg q2w
n=148 participants at risk
Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 300 mg q4w
n=157 participants at risk
Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
Dupilumab 200 mg q4w
n=150 participants at risk
Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.7%
20/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
10.9%
17/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
11.5%
17/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
12.1%
19/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
6.0%
9/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Bronchitis
|
10.1%
16/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
12.2%
19/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.4%
11/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.0%
11/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
6.7%
10/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Influenza
|
3.2%
5/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
5.8%
9/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.1%
6/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
8.3%
13/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
6.7%
10/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
15/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
10.3%
16/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
10.1%
15/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
12.1%
19/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
6.0%
9/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Pharyngitis
|
5.1%
8/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.2%
5/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.5%
7/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Sinusitis
|
7.0%
11/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.8%
6/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.4%
5/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
8.3%
13/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
8.0%
12/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Infections and infestations
Upper respiratory tract infection
|
17.7%
28/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
12.8%
20/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
14.9%
22/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
12.1%
19/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
14.7%
22/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
5/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.1%
11/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.7%
4/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.5%
7/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
3/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.8%
6/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.68%
1/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
5.7%
9/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
9/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.9%
3/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.5%
7/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.7%
7/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
6/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.7%
12/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
5.4%
8/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.5%
4/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.7%
7/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
General disorders
Injection site erythema
|
7.6%
12/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
21.8%
34/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
14.2%
21/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.6%
12/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
8.7%
13/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
General disorders
Injection site oedema
|
0.63%
1/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
5.1%
8/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.7%
4/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
1.3%
2/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
General disorders
Injection site pain
|
4.4%
7/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
9.0%
14/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
4.7%
7/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.8%
6/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
3.3%
5/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
|
General disorders
Injection site pruritus
|
3.2%
5/158 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
7.7%
12/156 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
6.8%
10/148 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
0.00%
0/157 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
2.0%
3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during 'treatment-emergent period' (from first dose of investigational product injection up to end of 16-week post-treatment period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER